Counter-torque implant

ABSTRACT

Implants with integral or modular anti-rotation features and related instruments are disclosed. The anti-rotation features do not preclude the implants from applying compression.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation-in-part of:

International Patent Application No. PCT/US2018/017229, filed Feb. 7,2018, entitled COUNTER-TORQUE IMPLANT.

International Patent Application No. PCT/US2018/017229 claims priorityto:

U.S. Provisional Patent Application No. 62/455,754, filed Feb. 7, 2017,entitled COUNTER-TORQUE IMPLANT, and

U.S. Provisional Patent Application No. 62/456,098, filed Feb. 7, 2017,entitled COUNTER-TORQUE IMPLANT.

The foregoing are incorporated by reference as though set forth hereinin their entirety.

The present application incorporates the following by reference asthough set forth herein in their entirety:

U.S. patent application Ser. No. 15/209,623, filed Jul. 13, 2016,entitled BONE PLATES WITH DYNAMIC ELEMENTS.

U.S. patent application Ser. No. 15/209,623 claims the benefit of:

U.S. Provisional Application No. 62/192,059, filed Jul. 13, 2015,entitled BONE PLATES WITH DYNAMIC ELEMENTS.

U.S. patent application Ser. No. 15/209,623 is a continuation-in-partof:

International Patent Application No. PCT/US2014/070495, filed Dec. 16,2014, entitled POLY AXIAL LOCKING HOLE.

International Patent Application No. PCT/US2014/070495 claims thebenefit of:

U.S. Provisional Patent Application No. 61/919,069, filed Dec. 20, 2013,entitled POLYAXIAL LOCKING HOLE.

U.S. patent application Ser. No. 15/209,623 is a continuation-in-partof:

International Patent Application No. PCT/US2015/039551, filed Jul. 8,2015, entitled BONE IMPLANT AND MEANS OF INSERTION.

International Patent Application No. PCT/US2015/039551 claims thebenefit of:

U.S. Provisional Patent Application No. 62/022,811, filed Jul. 10, 2014,entitled BONE IMPLANT AND MEANS OF INSERTION.

U.S. patent application Ser. No. 15/209,623 is a continuation-in-partof:

International Patent Application No. PCT/US2015/039556, filed Jul. 8,2015, entitled BONE IMPLANT WITH ANTI-ROTATION.

International Patent Application No. PCT/US2015/039556 claims thebenefit of:

U.S. Provisional Patent Application No. 62/022,811, filed Jul. 10, 2014,entitled BONE IMPLANT AND MEANS OF INSERTION; and

U.S. Provisional Patent Application No. 62/036,240, filed Aug. 12, 2014,entitled BONE IMPLANT WITH ANTI-ROTATION.

TECHNICAL FIELD

Implants for joint or bone fusion, and instrumentation for preparing ajoint or bones to receive an implant are disclosed. The implantsdisclosed may be used to compress and/or provide torsional stability toa joint, osteotomy, fracture, or interface between two bodies, at leasttwo bones, at least two bone portions, or at least two objects. Theimplants disclosed may be used in joint fusion procedures, fracturerepair, osteotomies, or other situations where is it desirable tocompress and/or provide rotational stability to two tissue portions.Each implant may also be referred to as a bone staple, clip, plate,fastener, and/or plug, and may include one or more integratedanti-torque features.

The disclosed technology includes an implant element, a plug, that isimplanted in the joint or interface so that a portion of the implantelement protrudes into each bone fragment. The plug resists forces suchas shear and rotation at the joint or interface. The plug may be a standalone implant or it may be combined with other implant elements, such asstaples, plates, and the like. When combined, the plug may be a separatepart or integrally formed with the other implant element(s). The plugdoes not interfere with dynamic compression provided by a staple becauseit is not restrained in the plane of compression, and in some examples,it may lie out of the plane of compression.

BACKGROUND

Successful bone fusion relies upon stable initial fixation of two ormore bone fragments or pieces. Until fusion is achieved, one or moreimplants must stabilize the bone fragments against relative translationand/or rotation in response to forces acting across the joint orinterface between the bone fragments.

SUMMARY

The various systems and methods of the present technology have beendeveloped in response to the present state of the art, and inparticular, in response to the problems and needs in the art that havenot yet been fully solved by currently available implants or clips andcorresponding instrument systems. The systems and methods of the presenttechnology may provide enhanced rotational stability across a joint,osteotomy, fracture, or other interface between two bone portions.

To achieve the foregoing, and in accordance with the technology asembodied and broadly described herein, in an aspect of the technology, asystem for stabilizing a first bone relative to a second bone, wherein ajoint separates the first and second bones, the system includes: adynamic implant having first and second legs connected by a bridge, andhaving a plug extending from a bone-facing side of the bridge, whereinthe plug has a cross-section that is elongated along a directionparallel to a line extending between the first and second legs, whereinthe implant has a free state in which the legs converge as they extendaway from the bridge, and an elastically deformed state in which thelegs are substantially parallel; and a drill guide having first andsecond lumens corresponding to the first and second legs of the implant,and having a slot corresponding to the center of the plug.

Embodiments of this aspect of the technology may further include a punchguide having first and second pegs corresponding to the first and secondlegs of the implant and the first and second lumens of the drill guide,and having a slot corresponding to the cross-section of the plug; and apunch having a cutting portion that has a cross-section that correspondsto the cross-section of the plug and the punch guide slot.

Another aspect of the technology is a method of stabilizing a first bonerelative to a second bone, wherein a joint separates the first andsecond bones, the method having the steps of:

preparing a first hole in the first bone guided by a drill guide;preparing a second hole in the second bone guided by the drill guide;providing a punch guide having an elongated slot and first and secondpegs; inserting the first peg of the punch guide into the first hole inthe first bone and inserting the second peg of the punch guide into thesecond hole in the second bone, so that the elongated slot of the punchguide extends across the joint; preparing a slot in the first and secondbones guided by the punch guide; providing an implant having anelongated bridge extending between opposite first and second ends, afirst leg extending transversely from the first end of the bridge, asecond leg extending transversely from the second end of the bridge, anda plug extending transversely from the bridge, wherein the plug has across-section that is elongated along a direction parallel to a planeestablished by the bridge, the first leg, and the second leg; implantingthe implant across the joint and in the first and second bones so thatthe first leg of the implant is in the first hole, the second leg of theimplant is in the second hole, the bridge of the implant extends acrossthe joint between the first and second legs, and the plug of the implantis in the slot in the first and second bones.

Yet another aspect of the technology is a bone plate system, having: abone plate having a bone-facing side, an opposite obverse side, firstand second receiver holes each extending through the plate between thebone-facing and obverse sides, first and second fastener holes eachextending through the plate between the bone-facing and obverse sides,and a plug extending outwardly from the bone-facing side and having across-section that is elongated along a direction parallel to a lineextending between the first and second receiver hole centers or a lineextending between the first and second fastener hole centers; and acompression bone staple having first and second legs connected by abridge, wherein the staple has a free state in which the legs convergeas they extend away from the bridge, and an elastically deformed statein which the legs are substantially parallel; wherein the staple iscoupled to the plate so that the first and second legs extend throughthe first and second receiver holes and protrude beyond the bone-facingside.

Yet another aspect of the technology is a method of stabilizing a firstbone relative to a second bone, wherein a joint separates the first andsecond bones, the method having the steps of: providing a bone platehaving a bone-facing side, an opposite obverse side, first and secondreceiver holes each extending through the plate between the bone-facingand obverse sides, first and second fastener holes each extendingthrough the plate between the bone-facing and obverse sides, and a plugextending outwardly from the bone-facing side and having a cross-sectionthat is elongated along a direction parallel to a line extending betweenthe first and second receiver hole centers or a line extending betweenthe first and second fastener hole centers; providing a compression bonestaple having first and second legs connected by a bridge, wherein thestaple has a free state in which the legs converge as they extend awayfrom the bridge, and an elastically deformed state in which the legs aresubstantially parallel; preparing a slot across the joint, wherein theslot has a cross-section that is elongated along a slot direction thatis transverse to the joint; preparing a first hole in the first bone anda second hole in the second bone, wherein the first and second holes arecentered on a line that is substantially parallel to the slot direction;placing a bone-facing side of a bone plate against the first and secondbones; inserting a plug of the plate into the slot, wherein the plugextends outwardly from the bone-facing side and has a cross-section thatis elongated complementary to the slot; placing first and secondreceiver holes of the plate over the first hole in the first bone andthe second hole in the second bone; and inserting first and second legsof a compression bone staple through the first and second receiver holesand into the first hole in the first bone and the second hole in thesecond bone.

These and other features and advantages of the present technology willbecome more fully apparent from the following description and appendedclaims, or may be learned by the practice of the technology as set forthhereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

Exemplary embodiments of the technology will become more fully apparentfrom the following description and appended claims, taken in conjunctionwith the accompanying drawings. Understanding that these drawings depictonly exemplary embodiments and are, therefore, not to be consideredlimiting of the scope of the technology, the exemplary embodiments willbe described with additional specificity and detail through use of theaccompanying drawings in which:

FIG. 1A is an isometric view of an implant comprising a compression bonestaple and an independent plug with the staple in a relaxed state; FIG.1B is a front view of the implant with the staple in an elasticallydeformed state; and FIG. 1C is a front view of the implant with thestaple in the relaxed state;

FIG. 2A is a front view of the staple of FIG. 1A in the relaxed state;and FIG. 2B is an isometric view of the staple of FIG. 1A in the relaxedstate;

FIG. 3A is an isometric view of the plug of FIG. 1A; FIG. 3B is a frontview of the plug of FIG. 1A; FIG. 3C is a side view of the plug of FIG.1A, the plug rotated 90° with respect to FIG. 3B; and FIG. 3D is anisometric view of an alternative embodiment of a plug;

FIG. 4A is an isometric view of a drill guide for use with the implantof FIG. 1A; FIG. 4B is a front view of the drill guide of FIG. 4A; FIG.4C is a top detail view of a guide portion of the drill guide of FIG.4A; and FIG. 4D is an isometric detail view of the guide portion of thedrill guide of FIG. 4A;

FIG. 5A is an isometric view of a joint between a first bone portion anda second bone portion, and pilot holes drilled into the joint and boneportions; FIG. 5B is an isometric view of the joint of FIG. 5A with theplug of FIG. 1A inserted into the joint; and FIG. 5C is an isometricview of the joint of FIG. 5A with the plug and clip of FIG. 1A insertedinto the pilot holes;

FIG. 6A is a front view of an implant comprising a compression bonestaple having an integrated anti-torque plug with the staple in arelaxed state; FIG. 6B is an isometric view of the implant of FIG. 6A;and FIG. 6C is a back view of the implant of FIG. 6A with the staple inan elastically deformed state;

FIG. 7A is a front view of another embodiment of an implant comprising acompression bone staple and an integrated anti-torque plug with thestaple in a relaxed state; and FIG. 7B is an isometric view of thestaple of FIG. 7A;

FIG. 8A is a top view of a joint between a first bone portion and asecond bone portion, and pilot holes drilled into the joint and boneportions; FIG. 8B is an isometric view of the joint of FIG. 8A, with theplug of FIG. 3D implanted in the joint; and FIG. 8C is an isometric viewof the joint of FIG. 8A with the implant of FIG. 6A and the independentanti-torque plug of FIG. 3D inserted into the joint;

FIG. 9A is an isometric view of an implant including a clip and aninterbody spacer; and FIG. 9B is an isometric view of the implant ofFIG. 9A with the clip joined to the spacer;

FIG. 10A is a side view of another embodiment of an implant comprising acompression bone staple and two integrated anti-torque plugs with thestaple in an elastically deformed state; FIG. 10B is an isometric viewof the implant of FIG. 10A and another interbody spacer; and FIG. 10C isan isometric view of the interbody spacer of FIG. 10B joined to theimplant of FIG. 10A;

FIG. 11A is an anterior view of an implant including a spacer and twoclips, implanted together in a tibiotalar joint; FIG. 11B is an obliqueview of the implant and tibiotalar joint of FIG. 11B; FIG. 11C is anisometric view of the implant of FIG. 11A; and FIG. 11D is an explodedisometric view of the implant of FIG. 11A;

FIG. 12A is an isometric anterior view of an implant including a spacerand two clips, implanted together in an intervertebral joint; FIG. 12Bis an isometric view of the implant of FIG. 12A; and FIG. 12C is anexploded isometric view of the implant of FIG. 12A;

FIG. 13 is a top view of another embodiment of an implant including ananti-torque plug;

FIG. 14 is a top view of another embodiment of an implant including ananti-torque plug;

FIG. 15A is an inferior isometric view of an implant include a platewith an anti-torque plug; FIG. 15B is a top view of the implant of FIG.15A; FIG. 15C is a front view of the implant of FIG. 15A; and FIG. 15Dis a partially exploded view of the implant of FIG. 15A;

FIG. 16A is a front view of another embodiment of an implant includingan anti-torque plug; FIG. 16B is an isometric view of the implant ofFIG. 16A; and FIG. 16C is another isometric view of the implant of FIG.16A;

FIG. 17A is a front view of another implant comprising a compressionbone staple having an integrated anti-torque plug; FIG. 17B is anisometric view of the implant of FIG. 17A; FIG. 17C is a bottom view ofthe implant of FIG. 17A; and FIG. 17D is a bottom oblique view of theimplant of FIG. 17A;

FIG. 18A is an isometric view of a drill guide for use with the implantof FIG. 17A; FIG. 18B is a front view of the drill guide of FIG. 18A;FIG. 18C is a top detail view of a guide portion of the drill guide ofFIG. 18A; and FIG. 18D is an isometric detail view of the guide portionof the drill guide of FIG. 18A;

FIG. 19A is an isometric view of a drill for use with the drill guide ofFIG. 18A; and FIG. 19B is a bottom oblique view of the drill of FIG.19A;

FIG. 20A is an exploded isometric view of a handle and a punch guidebody of a punch guide for use with the implant of FIG. 17A; and FIG. 20Bis another exploded isometric view of the handle and punch guide body ofFIG. 20A from a different direction;

FIG. 21A is an isometric view of a punch for use with the punch guide ofFIG. 20A; and FIG. 21B is another isometric view of the punch of FIG.21A from a different direction;

FIG. 22A is a front view of an implant inserter; FIG. 22B is a side viewof the implant inserter of FIG. 22A; FIG. 22C is a front cross-sectionalview of the implant inserter of FIG. 22A, taken along section line22C-22C of FIG. 22B; FIG. 22D is a side cross-sectional view of theimplant inserter of FIG. 22A, taken along section line 22D-22D of FIG.22A; FIG. 22E is an exploded isometric view of the implant inserter ofFIG. 22A; and FIG. 22F is another exploded isometric view of the implantinserter of FIG. 22A from a different direction;

FIG. 23 is an isometric view of a joint between a first bone portion anda second bone portion;

FIG. 24 is an isometric view of the joint of FIG. 23 with the drillguide of FIG. 18A positioned over the joint and the drill of FIG. 19Ainserted through the drill guide;

FIG. 25 is an isometric view of the joint of FIG. 24 with holes drilledin the first and second bone portions;

FIG. 26A is an isometric view of the joint of FIG. 25 with the assembledpunch guide of FIG. 20A engaged in the holes in the first and secondbone portions; and FIG. 26B is a cross-sectional view through the punchguide and bone portions of FIG. 26A;

FIG. 27A is an isometric view of the joint and punch guide of FIG. 26with the punch of FIG. 21A inserted through the punch guide; and FIG.27B is a cross-sectional view through the punch, punch guide, and boneportions of FIG. 27A;

FIG. 28 is an isometric view of the joint of FIG. 27 with a slot punchedinto the first and second bone portions and extending across the joint;

FIG. 29 is an isometric view of the joint of FIG. 28 with the implant ofFIG. 17A coupled to the implant inserter of FIG. 22A, the implant in aninsertion state;

FIG. 30 is an isometric view of the joint, implant, and implant inserterof FIG. 29 with the implant inserted into the holes and slot in thefirst and second bone portions;

FIG. 31 is a bottom oblique view of the implant of FIG. 17A coupled tothe implant inserter of FIG. 22A;

FIG. 32 is an isometric view of the joint and implant of FIG. 30 afterdisconnecting the implant inserter from the implant;

FIG. 33 is a cross-sectional view of the joint and implant of FIG. 32;

FIG. 34 is a perspective view of a system including a clip, an inserter,a drill guide assembly, a broach guide, a punch, a broach removal knob,a tamp, a k-wire, a reamer, and a bone pin;

FIG. 35 is a perspective view of the compression bone staple andinserter of FIG. 34;

FIG. 36 is another perspective view of the compression bone staple andinserter of FIG. 35 from a different direction;

FIG. 37 is a perspective exploded view of the compression bone stapleand inserter of FIG. 35;

FIG. 38 is another perspective exploded view of the compression bonestaple and inserter of FIG. 35 from a different direction;

FIG. 39 is a front view of the compression bone staple and inserter ofFIG. 35;

FIG. 40 is a right view of the compression bone staple and inserter ofFIG. 35;

FIG. 41 is a cross-sectional view of the compression bone staple andinserter of FIG. 35, taken along section line 41-41 of FIG. 40;

FIG. 42 is a cross-sectional view of the compression bone staple andinserter of FIG. 35, taken along section line 42-42 of FIG. 39;

FIG. 43 is a perspective view of the drill guide assembly of FIG. 34;

FIG. 44 is another perspective view of the drill guide assembly of FIG.43 from a different direction;

FIG. 45 is a perspective exploded detail view of a portion of the drillguide assembly of FIG. 43;

FIG. 46 is a perspective view of the punch and broach removal knob ofFIG. 34 operatively assembled together;

FIG. 47 is another perspective view of the punch and broach removal knobof FIG. 46 from a different direction;

FIG. 48 is a perspective exploded view of the punch and broach removalknob of FIG. 46;

FIG. 49 is a perspective view of the broach guide of FIG. 34;

FIG. 50 is another perspective view of the broach guide of FIG. 34 froma different direction;

FIG. 51 is an isometric view of an implant assembly including a boneplate and a compression bone staple;

FIG. 52 is an isometric view of the implant assembly of FIG. 51 from adifferent direction;

FIG. 53 is an isometric exploded view of the implant assembly of FIG.51;

FIG. 54 is another isometric exploded view of the implant assembly ofFIG. 51 from a different direction; and

FIG. 55 is a cross-sectional view of the implant assembly of FIG. 51taken along a mid-plane extending along the length of the plate.

DETAILED DESCRIPTION

Exemplary embodiments of the technology will be best understood byreference to the drawings, wherein like parts are designated by likenumerals throughout. It will be readily understood that the componentsof the technology, as generally described and illustrated in the figuresherein, could be arranged and designed in a wide variety of differentconfigurations. Thus, the following more detailed description of theembodiments of the apparatus, system, and method is not intended tolimit the scope of the invention, as claimed, but is merelyrepresentative of exemplary embodiments of the technology.

The phrases “connected to,” “coupled to” and “in communication with”refer to any form of interaction between two or more entities, includingmechanical, electrical, magnetic, electromagnetic, fluid, and thermalinteraction. Two components may be functionally coupled to each othereven though they are not in direct contact with each other. The term“abutting” refers to items that are in direct physical contact with eachother, although the items may not necessarily be attached together. Thephrase “fluid communication” refers to two features that are connectedsuch that a fluid within one feature is able to pass into the otherfeature.

The word “exemplary” is used herein to mean “serving as an example,instance, or illustration.” Any embodiment described herein as“exemplary” is not necessarily to be construed as preferred oradvantageous over other embodiments. While the various aspects of theembodiments are presented in drawings, the drawings are not necessarilydrawn to scale unless specifically indicated.

Standard medical planes of reference and descriptive terminology areemployed in this specification. While these terms are commonly used torefer to the human body, certain terms are applicable to physicalobjects in general.

A standard system of three mutually perpendicular reference planes isemployed. A sagittal plane divides a body into right and left portions.A coronal plane divides a body into anterior and posterior portions. Atransverse plane divides a body into superior and inferior portions. Amid-sagittal, mid-coronal, or mid-transverse plane divides a body intoequal portions, which may be bilaterally symmetric. The intersection ofthe sagittal and coronal planes defines a superior-inferior orcephalad-caudal axis. The intersection of the sagittal and transverseplanes defines an anterior-posterior axis. The intersection of thecoronal and transverse planes defines a medial-lateral axis. Thesuperior-inferior or cephalad-caudal axis, the anterior-posterior axis,and the medial-lateral axis are mutually perpendicular.

Anterior means toward the front of a body. Posterior means toward theback of a body. Superior or cephalad means toward the head. Inferior orcaudal means toward the feet or tail. Medial means toward the midline ofa body, particularly toward a plane of bilateral symmetry of the body.Lateral means away from the midline of a body or away from a plane ofbilateral symmetry of the body. Axial means toward a central axis of abody. Abaxial means away from a central axis of a body. Ipsilateralmeans on the same side of the body. Contralateral means on the oppositeside of the body. Proximal means toward the trunk of the body. Proximalmay also mean toward a user or operator. Distal means away from thetrunk. Distal may also mean away from a user or operator. Dorsal meanstoward the top of the foot. Plantar means toward the sole of the foot.Varus means deviation of the distal part of the leg below the kneeinward, resulting in a bowlegged appearance. Valgus means deviation ofthe distal part of the leg below the knee outward, resulting in aknock-kneed appearance.

In this specification, “substantially” means ±20% for linear dimensionsand ±20° for angular dimensions.

In this specification, the terms “keel” and “plug” are usedinterchangeably to refer to a feature that extends into or across ajoint or other interface between two bone portions.

Referring to FIGS. 1A-1C and 5C, an implant 100 includes a plug 150 anda clip 200. It is appreciated that the plug 150 and clip 200 may be usedtogether as implant 100; however, each may also be used independently.One or more implants 100, clips 200, and/or plugs 150 may be implantedin a single procedure, for example to join two bone portions together.

Referring to FIGS. 2A and 2B, the clip 200 includes bone engagingmembers 202 and 204 which may be integral to a clip bridge 206, alsoreferred to as a clip body. The bone engaging members 202 and 204 may bereferred to as legs or fixation elements. In other embodiments withinthe scope of the disclosure, a clip may include more than two boneengaging members; or alternatively may include openings for one or moreindependent fasteners in lieu of integrated bone engaging members. Thebone engaging member 202 extends from a left end 230 of the clip bridge206 and the bone engaging member 204 extends from an opposite right end232 of the clip bridge 206. Bone engaging member 202 has a proximal end234 attached to the left end 230 of the clip bridge 206 and an oppositedistal end 236 which is a free end. Bone engaging member 204 has aproximal end 238 attached to the right end 232 of the clip bridge 206and an opposite distal end 240 which is a free end. Clip bridge 206 hasan upper or proximal surface 208 and a lower surface 210. The lowersurface 210 may be referred to as a bone facing surface or distalsurface. Bone engaging member 202 extends from the lower surface 210beside bone engaging member 204. The bone engaging members 202 and 204may have features 212 that may improve bone purchase or improve pull outstrength of the clip 200 from bone or soft tissue. The features 212 maybe referred to as teeth or serrations. The features 212 are shown onfacing sides of the bone engaging members 202, 204 but may be on any orall sides of the bone engaging members. The clip 200 may haveprojections or other connecting means 214 and 216 for connection with ameans of insertion. The connecting means 214, 216 may be referred to astabs, ears, protrusions, wings, retainers, connection features, orretaining members. The connecting means 214 and 216 are shown extendingsideways outwardly from the left and right ends 230, 232 of the bridge206, respectively, along a longitudinal direction established by thebridge. In other embodiments, the connecting means may projectperpendicularly with respect to the bridge. The connecting means 214 and216 may have lower surfaces 218 and 220 respectively that may releasablyengage with a means of insertion that may allow an inserter or othermeans of insertion to be side loading, top loading or pivotably loaded.For example, an inserter for clip 200 may be side loading or pivotablyloading. The lower surfaces 218, 220 may be referred to as bone facingsurfaces or distal surfaces. Referring to FIG. 2A, the lower surfaces218, 220 are proximally spaced apart from, or proximally offset from,the lower surface 210 toward the upper surface 208. The dashed extensionlines 210′ and 210″ in FIG. 2A show the level of the lower surface 210versus the lower surfaces 218, 220.

A means of insertion may maintain the clip 200 in a first configurationthereby allowing a second configuration once an inserter is disassembledfrom the implant. The first configuration may be an elastically deformedstate, for example an insertion state, as seen in FIG. 1B. The secondconfiguration may be a free state or an implanted state, as seen inFIGS. 1A, 1C, and 2A. The means of insertion may utilize featuressimilar to connecting means 214 and 216 in combination with othersurfaces such as top surface 208. This combination of means of insertionmay be used to maintain one or more features or arms or projections in aparticular configuration. This combination of means of insertion maycreate a bending modality, such as a three point or four point bend, tomaintain a specific clip device configuration or combination ofconfigurations. A combination of surfaces and means of insertion, suchas connecting means 214, may be used on the entire clip or portions of aclip to create or maintain a particular configuration of a clip. Forexample, a tab such as 214 and top surface, such as 208 may be used tomaintain one side of a clip or one leg of a clip in a particularconfiguration. When disassembled, that leg may have a configuration thatis different from or the same as the configuration of the rest of theclip.

Referring to FIGS. 2A-2B, the clip 200 is shown in the free state, orrelaxed state, which is the shape of the clip 200 when no externalforces are acting upon the clip 200, other than gravity; the clip 200experiences no elastic or plastic deflection or deformation. In the freestate, the bone engaging members 202 and 204 converge as they extendaway from the bridge 206 so that the distal ends 236, 240 are closertogether than are the proximal ends 234, 238. An angle 222 is formedbetween the converging bone engaging members 202 and 204 in the freestate. The angle 222 opens toward the bridge 206. The angle 222 may bereferred to as a free state angle.

Referring to FIGS. 1A-1C and 3A-3C, plug 150 extends between a proximalor first end 154 and a distal or second end 156, along a longitudinalaxis 158. A plug head 160 is at the first end 154, separated from a plugtip 162 by a plug body 152. The plug head 160 may include a slot orchannel 164 shaped to complementarily receive the clip bridge 206, thechannel flanked by opposing first and second rails 166, 168. From asuperior or top down perspective, the plug head 160 may have a circularperimeter, whereas the body 152 is generally rectangular incross-section, in order to prevent rotation of the plug 150 onceinserted. The thickness of the body 152, perpendicular to the slot 164,may be the same as or similar to the thickness of the bridge 206 and/orbone engaging members 202, 204 of the clip 200 in the same direction(front-back), or the body 152 may be thicker or thinner than the clip200. Preferably, the body 152 is thinner than the bone engaging members202, 204. The plug tip 162 is tapered to facilitate insertion into bone.One or more sides of the plug body 152 and/or tip 162 may includefeatures 170 that may improve bone purchase. The features 170 may bereferred to as teeth or serrations. The features 170 are shown onopposing sides of the plug body 152 and tip 162, but may be on any orall sides. In an embodiment, features 170 may be absent. In otherembodiments, the cross-sectional shape of the body may be rectangular,triangular, round, double-barrel or another shape.

Referring to FIGS. 4A-4D, a drill guide 300 may be employed to preparepilot holes for implant 200 in a joint 2 between a first bone 4 and asecond bone 6. The joint 2 may be an actual anatomical joint, anosteotomy, a fracture, or an interface between the first and secondbones 4, 6. Drill guide BOO may include a handle portion 302 and a guideportion 304; some embodiments may exclude the handle portion 302. Theguide portion 304 includes a guide bar 310 from which one or more guideelements may depend. In the embodiment depicted, guide portion 304includes first and second single hole guide elements 312, 314 whichflank a multi-hole guide element 316. Of course, other embodiment of thedrill guide 300 can include any number and arrangement of guideelements; and in other embodiments the guide elements may not dependfrom the guide bar. Guide element 312 surrounds and supports a firstlumen 322; guide element 314 surrounds and supports a second lumen 324,and guide element 316 surrounds and supports a third lumen 326. All theguide elements may include pointed or tapered tips to facilitateengagement with bone or tissues during the drilling procedure. Guideelement 316 includes a wedge 318 which may be aligned with a joint 2 tocontrol placement of the pilot holes with respect to the joint 2, duringa drilling procedure.

In the embodiment depicted, the first and second lumens 322, 324 arecircular in a transverse cross section, and each are shaped to guide adrill for drilling a single bore. The third lumen 326 includes threeoverlapping lumens 327, 328, 329. In a transverse cross section, thethird lumen 326 has the shape of three overlapping circles, which may becalled a “snowman shape.” The elongated transverse shape of the thirdlumen 326 allows a single drill to be used to create a pilot hole largeenough to receive the plug 150. In other embodiments, the third lumenmay have an oval, circular, figure eight, rectangular, or other shapecross-sectional shape which provides a line to line or interference fitbetween the lumen and the plug upon insertion of the plug. In theembodiment shown, the first, second and third lumens 322, 324, 326 areco-planar. In other embodiments, one or more of the lumens may be out ofthe plane of the others.

Referring to FIGS. 4A-5C, a method of insertion of implant 100 isdescribed. Drill guide 300 is positioned adjacent the first and secondbone portions 4, 6, with guide portion 304 spanning the joint 302. Theguide portion 304 may be impacted, with wedge 318 positioned in joint 2.Wedge 318 may be pressed, impacted or otherwise aligned into the joint2, to ensure proper alignment of the drill guide with respect to thejoint 2, and may ensure that the pilot holes are centered with respectto the joint line. Pilot holes 352, 354, and 356 are drilled into thebone portions 4, 6 and joint 2. Residual material 358, which may be inthe form of ridges, may be left in pilot hole 356. This residualmaterial may create interference for the plug 150 providing a tight fitof the plug in the pilot hole 356.

Referring to FIG. 5B, plug 150 is inserted into the pilot hole 356 andin contact with bone portions 4, 6. Thus positioned in the joint, theplug provides stability to the joint, and provides resistance to forcesacting on the joint, including shear and rotational forces. Head 160 ofthe plug is oriented so that channel 164 is approximately perpendicularto the joint 2, and is aligned in the same plane with outboard pilotholes 352, 354. Referring to FIG. 5C, clip 200 is inserted with bridge206 approximately perpendicular to the joint 2. During the insertionprocedure, a means of insertion such as an instrument may flex clip 200toward the insertion state to urge leg distal ends 236, 240 away fromone another. Bone engaging member 202 is inserted in pilot hole 352, andbone engaging member 204 is inserted in pilot hole 354. Clip bridge 206is received in channel 164, preventing rotation of the clip 200 onceinserted, and preventing rotation of the bone portions 4, 6 relative toone another.

In an alternative embodiment shown in FIG. 3D, a plug 180 includes ahead 190 which lacks a channel. When implant into a joint as describedabove, plug 180 may be offset from the plane of corresponding implant200, as shown in FIGS. 8B and 8C. Drill guide 300 may be used to preparean offset pilot hole 366. Plug 180 may be implanted independently as astand-alone implant, or may be implanted with a staple such as clip 200or others disclosed herein. In another embodiment, plug 150 may beimplanted to be offset from the plane of clip 200. Whether implantedindependently into a joint, or with a clip 200, the plug 180 may providetorsional stability, preventing rotation of the bone portions 4, 6relative to one another, and/or preventing shear forces from acting uponthe joint.

In other embodiments within the scope of the disclosure, plug 150 may beimplanted with another corresponding implant such as a bone plate. Theplug and bone plate combination may be implanted across a joint betweentwo bones, bodies or devices to resist rotation of the bodies about thejoint. The bone plate may have two or more openings for fasteners, and afeature to cooperatively connect with plug 150.

Referring to FIGS. 6A-6C, a clip 1100 includes an integrated anti-torqueplug 1150. Clip 1100 and other clips disclosed herein may also bereferred to as a fastener, staple, or implant. Anti-torque plug 1150 andother anti-torque features disclosed herein may also be referred to as atab, keel, post, or implant. FIGS. 7A-7B show an alternate embodiment ofan implant; clip 1200 includes an integrated anti-torque plug 1250 whichhas a chisel-shaped tip. FIG. 3D shows an independent anti-torque plug180. One or more clips 1100, 1200, plates and/or plugs 180 disclosedherein may be implanted in a single procedure, for example to join twobone portions together.

Referring to FIGS. 6A and 6B, the clip 1100 includes bone engagingmembers 1102 and 1104 which may be integral to a clip bridge 1106, alsoreferred to as a clip body. The bone engaging members 1102 and 1104 maybe referred to as legs. In other embodiments within the scope of thedisclosure, a clip may include more than two bone engaging members; oralternatively may include openings for one or more independent fastenersin lieu of the bone engaging members. In other embodiments of thedisclosure, the implant 1100 may be more similar to a plate. The boneengaging member 1102 extends from a left end 1130 of the clip bridge1106 and the bone engaging member 1104 extends from an opposite rightend 1132 of the clip bridge 1106. Bone engaging member 1102 has aproximal end 1134 attached to the left end 1130 of the clip bridge 1106and an opposite distal end 1136 which is a free end. Bone engagingmember 1104 has a proximal end 1138 attached to the right end 1132 ofthe clip bridge 1106 and an opposite distal end 1140 which is a freeend. Clip bridge 1106 has at least one upper or proximal surface 1108and at least one lower or distal surface 1110. The lower surface 1110may be referred to as a bone facing surface. Bone engaging member 1102extends from the lower surface 1110 beside bone engaging member 1104.The bone engaging members 1102 and 1104 may have features 1112 that mayimprove bone purchase or improve pull out strength of the clip 1100 frombone or soft tissue. The features 1112 may be referred to as teeth orserrations. The features 1112 are shown on facing sides of the boneengaging members 1102, 1104 but may be on any or all sides of the boneengaging members. The clip 1100 may have projections or other connectingmeans 1114 and 1116 for connection with a means of insertion. Theconnecting means 1114, 1116 may be referred to as tabs, ears,protrusions, wings, retainers, or retaining members. The connectingmeans 1114 and 1116 are shown extending sideways outwardly from the leftand right ends 1130, 1132 of the bridge 1106, respectively, along alongitudinal direction established by the bridge. In other embodiments,the connecting means may project perpendicularly with respect to thebridge. The connecting means 1114 and 1116 may have lower or distalsurfaces 1118 and 1120 respectively that may releasably engage with ameans of insertion that may allow an inserter or other means ofinsertion to be side loading, top loading or pivotably loaded. Forexample, an inserter for clip 1100 may be side loading or pivotablyloading. The lower surfaces 1118, 1120 may be referred to as bone facingsurfaces. Referring to FIG. 6A, the lower surfaces 1118, 1120 areproximally spaced apart from, or proximally offset from, the lowersurface 1110. The dashed extension lines 1110′ and 1110″ in FIG. 6A showthe level of the lower surface 1110 versus the lower surfaces 1118,1120.

An integrated anti-torque plug 1150 projects distally from the lowersurface 1110 of bridge 1106. In the embodiment depicted, a single plug1150 is centered between bone engaging members 1102, 1104; in otherembodiments the plug may be off-center relative to the members 1102,1104, and/or a plurality of plugs may be included. The plug may also beconnected to the implant 1100 in more than one location along the lowersurface 1110 of bridge 1106. Plug 1150 includes a neck portion 1152where the plug is joined to bridge 1106, a body 1154, and a tip 1156.Neck portion 1152 may be formed as a waist having a reduced width withrespect to the plug body 1154 as shown in FIGS. 6A-6C; in otherembodiments the neck portion 1152 may be wider than or equal in widthwith respect to the plug body 1154. Preferably, plug 1150 is connectedto the clip 1100 only via the bridge 1106, and not along the boneengaging members 1102, 1104. Plug 1150 may be rectangular incross-section and includes four sides 1160, 1162, 1164, 1166. The plugthickness between sides 1160 and 1166 may be less than, the same as,similar to, or greater than the thickness of the bridge 1106 and/or boneengaging members 1102, 1104 of the clip 1100 in the same direction(front-back). Preferably, the plug thickness between sides 1160 and 1166is less than the thickness of the bone engaging members 1102, 1104 inthe same direction. The plug tip 1156 may be tapered on at least twosides 1162, 1164 with respect to the plug body to facilitate insertioninto a joint. The plug sides 1160, 1162, 1164, 1166 may be smooth asseen in FIGS. 6A-6C; in other embodiments one or more plug sides mayinclude teeth, serrations, or other surface roughening. In otherembodiments, the plug may have a differently shaped cross-section. Theplug does not preclude compression of the bone segments by the boneengaging members 1102, 1104, at least because the plug is oriented in aplane coplanar with, or parallel to, the plane of the bridge 1106 andbone engaging members 1102, 1104 of the clip 1100.

A means of insertion may maintain the clip 1100 in a first configurationthereby allowing a second configuration once an inserter is disassembledfrom the implant. The first configuration may be an elastically deformedstate, for example an insertion state, as seen in FIG. 6C. The secondconfiguration may be a free state or an implanted state, as seen inFIGS. 6A and 6B. The means of insertion may utilize features similar toconnecting means 1114 and 1116 in combination with other surfaces suchas top surface 1108. This combination of means of insertion may be usedto maintain one or more features or arms or projections in a particularconfiguration. This combination of means of insertion may create abending modality, such as a three point or four point bend, to maintaina specific clip device configuration or combination of configurations. Acombination of surfaces and means of insertion, such as connecting means1114, may be used on the entire clip or portions of a clip to create ormaintain a particular configuration of a clip. For example, a tab suchas 1114 and top surface, such as 1108 may be used to maintain one sideof a clip or one leg of a clip in a particular configuration. Whendisassembled, that leg may have a configuration that is different fromor the same as the configuration of the rest of the clip.

Referring to FIGS. 6A-6B, the clip 1100 is shown in the free state, orrelaxed state, which is the shape of the clip 1100 when no externalforces are acting upon the clip 1100, other than gravity; the clip 1100experiences no elastic or plastic deflection or deformation. In the freestate, the bone engaging members 1102 and 1104 converge as they extendaway from the bridge 1106 so that the distal ends 1136, 1140 are closertogether than are the proximal ends 1134, 1138. An angle 1122 is formedbetween the converging bone engaging members 1102 and 1104 in the freestate. The angle 1122 opens toward the bridge 1106. The angle 1122 maybe referred to as a free state angle.

Referring to FIGS. 7A-7B, an alternative embodiment of an implant withan integrated anti-torque plug is shown. Clip 1200 includes a firstbone-engaging member 1202, a second bone-engaging member 1204, a bridge1206, and an integrated anti-torque plug 1250. The descriptions of thebone engaging members, bridge and anti-torque plug of clip 1100 areapplicable to clip 1200. In addition, the descriptions of the freestate, the elastically deformed state, and means of insertion of clip1100 are also applicable to clip 1200. The anti-torque plug 1250 of clip1200 includes neck 1252 and body 1254 portions, as described for clip1100. A tip portion 1256 of clip 1200 is tapered on all four sides withrespect to the body 1254, to form a chisel or wedge shape. Otherembodiments may include tip portions having other taper shapes in whichone or more sides of the tip is tapered with respect to the body. Inother embodiments, the taper may extend along one or more body portionsides.

Referring to FIG. 3D, an independent anti-torque plug 180 extendsbetween a proximal or first end 182 and a distal or second end 184,along a longitudinal axis 186. A plug head 190 is at the first end 182,separated from a plug tip 188 by a plug body 192. From a superior or topdown perspective, the plug head 190 may have a circular perimeter,whereas the body 192 is generally rectangular in cross-section, in orderto prevent rotation of the plug 180 once inserted. The plug tip 188 istapered to facilitate insertion into bone. One or more sides of the plugbody 192 and/or tip 188 may include features 194 that may improve bonepurchase. The features 194 may be referred to as teeth or serrations.The features 194 are shown on opposing sides of the plug body 192 andtip 188, but may be on any or all sides. In an embodiment, features 194may be absent. In other embodiments, the cross-sectional shape of thebody 192 may be rectangular, triangular, round, double-barrel or anothershape. One or more plugs 180 may be implanted independently in a jointto prevent rotation of the bones or bodies about the joint, and/or oneor more plugs 180 may be implanted in conjunction with any of the clipsdisclosed herein, as in FIG. 8C, to provide additional joint stability.

Referring to FIGS. 4A-4D, the drill guide BOO may be employed to preparepilot holes for implants 180, 1100, 1200 or any implant disclosedherein, in a joint 2 between a first bone 4 and a second bone 6. Thejoint 2 may be an actual anatomical joint, an osteotomy, a fracture, oran interface between the first and second bones 4, 6. Drill guide BOOmay be used to prepare a joint for implantation of any of the implantsdisclosed herein. Other instrumentation may be used to prepare a site toreceive one or more of the implants described herein, including punches,drills, saws, sawblades, or any other instrument capable of creating anopening through the tissue, bone or joint material.

Referring to FIGS. 4A-4D and 8A-8C, a method of insertion of implant1100 is described. It is understood that the method of insertion mayemployed for any of the implants described herein. Drill guide 300 ispositioned adjacent the first and second bone portions 4, 6, with guideportion 304 spanning the joint 2. The guide portion 304 may be impacted,with wedge 318 positioned in joint 2. Wedge 318 may be pressed, impactedor otherwise aligned into the joint 2, to ensure proper alignment of thedrill guide with respect to the joint 2, and may ensure that the pilotholes are centered with respect to the joint line. Pilot holes 352, 354,and 356 are drilled into the bone portions 4, 6 and joint 2. Residualmaterial 358, which may be in the form of ridges, may be left in pilothole 356. This residual material may create interference for the plug1150 providing a tight fit of the plug in the pilot hole 356. Ifdesired, another pilot hole 366 may be created for implantation of anindependent anti-torque plug 180. Pilot hole 366 may be drilled in joint2, and may be offset from pilot holes 352, 354, and 356.

Referring to FIG. 8C, clip 1100 is inserted into the pilot holes 352,354, 356, with bridge 1106 approximately perpendicular to the joint 2.During the insertion procedure, a means of insertion such as aninstrument may flex clip 1100 toward the insertion state to urge legdistal ends 1136, 1140 away from one another. Bone engaging member 1102is inserted into pilot hole 352, bone engaging member 1104 is insertedinto pilot hole 354, and plug 1150 is inserted into the joint, in pilothole 356 and in contact with bone portions 4, 6. Thus positioned in thejoint, the plug 1150 provides stability to the joint, and providesresistance to forces acting on the joint, including shear and rotationalforces. Before or after insertion of clip 1100, an auxiliary independentanti-torque plug 180 may be implanted in optional pilot hole 366. Theplug 180 may be oriented so that features 70 are approximatelyperpendicular to the joint 2, in order to provide an interference fitwith any residual material in pilot hole 366. Plug 180 may be offsetfrom the plane of the bone engaging members 1102, 1104 and plug 1150 ofclip 1100.

Clips disclosed herein may also be implanted in combination with aspacer or other interbody device. Referring to FIGS. 9A and 9B, implant1400 includes a clip 1500 and a spacer 1450. The description of clip1100 may apply to clip 1500, with the exception that clip 1500 includesa plug 1550 having neck portion 1552 which may be greater to or equal inwidth to the body of the plug. Spacer 1450 includes a body 1452, and mayhave one or more fenestrations 1454 for insertion of bone graft materialand/or for bone in-growth. Spacer 1450 also includes a slot 1456 shapedto receive a plug such as plug 1550, and may form an interference fitwith neck 1552 when joined with the plug as shown in FIG. 9B. In amethod of implantation, spacer 1450 may be joined to clip 1500, and theresultant implant 1400 may be implanted as a unit. Alternately, spacer1450 may be implanted into a prepared joint space first, and then clip1500 may be implanted, with slot 1456 receiving plug 1550.

Referring to FIGS. 10A-10C, implant 1600 includes a clip 1700 and aspacer 1650. The description of clip 1100 may apply to clip 1700, withthe exception that clip 1700 includes two anti-torque plugs 1750, 1770.Each anti-torque plug 1750, 1770 may include a neck portion 1752, 1772which may taper outward from the neck to the clip bridge 1706. Spacer1650 includes a body 1652, and may have one or more fenestrations 1654for insertion of bone graft material and/or for bone in-growth. Spacer1650 also includes slots 1656, 1658 shaped to receive plugs 1750, 1770,which may form an interference fit when the spacer 1650 joined with theplugs as shown in FIG. 10C. In a method of implantation, spacer 1650 maybe joined to clip 1700, and the resultant implant 1600 may be implantedas a unit into a joint between two bodies, for example two bones.Alternately, spacer 1650 may be implanted into a prepared joint spacefirst, and then clip 1700 may be implanted, with slots 1656, 1658receiving plugs 1750, 1770. When implanted as described, the inner ormedial facing surfaces of plugs 1750, 1770 interfere with spacer 1650,and the outer or lateral facing surfaces of plugs 1750, 1770 interferewith the bone(s) in which they are implanted. This may prevent rotationor counteraction forces between the bone(s) and the implant, while alsopreventing rotation of the bones with respect to one another.

Referring to FIGS. 11A-12C, additional examples of implants comprisingclips and spacers are shown. FIGS. 11A and 11B depict an implant 1800implanted into a tibiotalar joint between a tibia 8 and a talus 10.FIGS. 11C and 11D illustrate that implant 1800 comprises two clips 1500in combination with a spacer 1850. FIG. 12A depicts an implant 1900implanted into an intervertebral joint between a first vertebra 12 and asecond vertebra 14. FIGS. 12B and 12C illustrate that implant 1900comprises two clips 1500 in combination with a spacer 1950.

Referring to FIG. 13, another embodiment of an implant with anassociated keel is shown. Implant 2000 includes implant body 2006, andkeel 2050 which projects away from implant body 2006. Implant 2000 mayinclude one or more bone engagement features 2002, 2004 to fasten theimplant 2000 to bone, tissue, and/or another device. Bone engagementfeatures 2002, 2004 may be integrated into implant body 2006, forexample as posts, legs, or pins; or may be separate fasteners such asscrews. The implant 2000 may include a first configuration which is anelastically deformed state for insertion, and a second configurationwhich is a relaxed or free state when implanted, as described above forimplants 1100, 1200. In the embodiment shown, the keel 2050 has astar-shaped cross-sectional shape, with four flanges or lobes 2052,2054, 2056, 2058 protruding from a central keel body 2060. A distal tipof the keel may be tapered to facilitate introduction into a joint. Thekeel 2050 may be integrally formed with the implant body 2006 as onepiece, or may be a separate entity joined to the implant body before orduring implantation. Implant 2000 may be implanted according to themethods described above for implants 1100, 1200. When implanted in ajoint, the flanges 2052, 2054, 2056, 2058 can have an interference fitwith the surrounding joint tissues, to resist rotation and shear forcesaround the joint.

Referring to FIG. 14, another embodiment of an implant with anassociated keel is shown. Implant 2100 includes implant body 2106, andkeel 2150 which projects away from implant body 2106. Implant 2100 mayinclude one or more bone engagement features 2102, 2104 to fasten theimplant 2100 to bone, tissue and/or another device. Bone engagementfeatures 2102, 2104 may be integrated into implant body 2106, forexample as posts, legs, or pins; or may be separate fasteners such asscrews. The implant 2100 may include a first configuration which is anelastically deformed state for insertion, and a second configurationwhich is a relaxed or free state when implanted, as described above forimplants 1100, 1200. In the embodiment shown, the keel 2150 includesfour longitudinal edges 2152, 2154, 2156, 2158 projecting from a centralkeel body 2160. A distal tip of the keel may be tapered to facilitateintroduction into a joint. The keel 2150 may be integrally formed withthe implant body 2106 as one piece, or may be a separate entity joinedto the implant body before or during implantation. Implant 2100 may beimplanted according to the methods described above for implants 1100,1200. When implanted in a joint, the edges 2152, 2154, 2156, 2158 canhave an interference fit with the surrounding joint tissues, to resistrotation and shear forces acting on the joint.

Referring to FIGS. 15A-15D, another embodiment of an implant with anassociated keel is shown. Implant 2200 includes a plate 2206 and a keel2250. The plate 2206 depicted includes openings for a plurality of bonescrews 2280 for fastening the plate 2206 across a joint between twobones or bodies. In other embodiments, fasteners may be formedintegrally with the plate 2206. In the embodiment depicted, the keel2250 is received in a slot 2202 in the plate and projects inferiorlybelow the plate. In other embodiments, the keel may be formed integrallywith the plate, as shown for implants 1100, 1200. In a method ofimplantation, drill guide BOO may be used to create a pilot hole forkeel 2250 in a joint 2 between first second bodies 4, 6. Plate 2206 maybe oriented perpendicular to the joint and fastened to the bodies 4, 6with fasteners 2280. Keel 2250 may be inserted through slot 2202 andinto the joint 2. Keel 2250 may be fastened to the plate 2206. In othermethods of implantation, keel 2250 may be joined to the plate 2206before implantation. The keel 2250 may be replaced by implant 1100,1200, 1500, 1700, 2000, or 2100. It is appreciated that within the scopeof the disclosure, other shapes or configurations of plates may includean integrated or associated keel.

It is appreciated that in other embodiments of the disclosure, keels1150, 1250, 2060, 2160, 2250 and other keels disclosed herein may haveother shapes, including but not limited to square, rectangular,triangular, star, and/or irregular or asymmetric. The keels disclosedherein may also have rounded shapes, if they are sufficiently sized toprovide an interference fit with the surrounding tissues or bodies inwhich they are implanted, in order to resist rotation and shear forces.

Referring to FIGS. 16A-16C, another embodiment of an implant with anintegrated counter-torque feature is shown. Implant 2300 includes firstand second bone engagement members 2302, 2304 and an implant body 2306.The implant 2300 may include a first configuration which is anelastically deformed state for insertion, and a second configurationwhich is a relaxed or free state when implanted, as described above forimplants 1100, 1200. The implant 2300 includes protrusion 2350 whichprojects inferiorly from the implant body 2306. Implant 2300 may beimplanted into a joint, as described previously for implants 1100, 1200.Protrusion 2350 is received in joint 2 and may form an interference fitin a prepared pilot hole, and the bone engagement members 2302, 2304 mayprovide compression across the joint. The protrusion 2350 may providestability to the joint and resist rotation and shear forces acting onthe joint.

Referring to FIGS. 17A-17D, another implant or clip 2400 includes anintegrated anti-torque plug 2450. Clip 2400 and other clips disclosedherein may also be referred to as a fastener, staple, or implant.Anti-torque plug 2450 and other anti-torque features disclosed hereinmay also be referred to as a tab, keel, post, or implant. One or moreclips 2400 may be implanted in a single procedure, for example to jointwo bone portions together.

Referring to FIGS. 17A and 17B, the clip 2400 includes bone engagingmembers 2402 and 2404 which may be integral to a clip bridge 2406, alsoreferred to as a clip body. The bone engaging members 2402 and 2404 maybe referred to as legs. In other embodiments within the scope of thedisclosure, a clip may include more than two bone engaging members; oralternatively may include openings for one or more independent fastenersin lieu of the bone engaging members. In other embodiments of thedisclosure, the implant 2400 may be more similar to a plate. The boneengaging member 2402 extends from a left end 2430 of the clip bridge2406 and the bone engaging member 2404 extends from an opposite rightend 2432 of the clip bridge 2406. Bone engaging member 2402 has aproximal end 2434 attached to the left end 2430 of the clip bridge 2406and an opposite distal end 2436 which is a free end. Bone engagingmember 2404 has a proximal end 2438 attached to the right end 2432 ofthe clip bridge 2406 and an opposite distal end 2440 which is a freeend. Clip bridge 2406 has at least one upper or proximal surface 2408and at least one lower or distal surface 2410. The lower surface 2410may be referred to as a bone facing surface. Bone engaging member 2402extends from the lower surface 2410 beside bone engaging member 2404.The bone engaging members 2402 and 2404 may have features 2412 that mayimprove bone purchase or improve pull out strength of the clip 2400 frombone or soft tissue. The features 2412 may be referred to as teeth orserrations. The features 2412 are shown on facing sides of the boneengaging members 2402, 2404 but may be on any or all sides of the boneengaging members. The clip 2400 may have projections or other connectingmeans 2414 and 2416 for connection with a means of insertion. Theconnecting means 2414, 2416 may be referred to as tabs, ears,protrusions, wings, retainers, or retaining members. The connectingmeans 2414 and 2416 are shown extending sideways outwardly from the leftand right ends 2430, 2432 of the bridge 2406, respectively, along alongitudinal direction established by the bridge. In other embodiments,the connecting means may project perpendicularly with respect to thebridge. The connecting means 2414 and 2416 may have lower or distalsurfaces 2418 and 2420 respectively that may releasably engage with ameans of insertion that may allow an inserter or other means ofinsertion to be side loading, top loading or pivotably loaded. Forexample, an inserter for clip 2400 may be side loading or pivotablyloading. The lower surfaces 2418, 2420 may be referred to as bone facingsurfaces. Referring to FIG. 17A, the lower surfaces 2418, 2420 areproximally spaced apart from, or proximally offset from, the lowersurface 2410. The dashed extension lines 2410′ and 2410″ in FIG. 17Ashow the level of the lower surface 2410 versus the lower surfaces 2418,2420.

An integrated anti-torque plug 2450 projects distally from the lowersurface 2410 of bridge 2406. In the embodiment depicted, a single plug2450 is centered between bone engaging members 2402, 2404; in otherembodiments the plug may be off-center relative to the members 2402,2404, and/or a plurality of plugs may be included. The plug may also beconnected to the implant 2400 in more than one location along the lowersurface 2410 of bridge 2406. Plug 2450 includes a neck portion 2452where the plug is joined to bridge 2406, a body 2454, and a tip 2456.Neck portion 2452 may be formed as a waist having a reduced width withrespect to the plug body 2454 as shown in FIGS. 17A-17D; in otherembodiments the neck portion 2452 may be wider than or equal in widthwith respect to the plug body 2454. Preferably, plug 2450 is connectedto the clip 2400 only via the bridge 2406, and not along the boneengaging members 2402, 2404. Plug 2450 may be rectangular incross-section and includes four sides 2460, 2462, 2464, 2466. The plugthickness between sides 2460 and 2466 may be less than, the same as,similar to, or greater than the thickness of the bridge 2406 and/or boneengaging members 2402, 2404 of the clip 2400 in the same direction(front-back). Preferably, the plug thickness between sides 2460 and 2466is less than the thickness of the bridge and bone engaging members 2402,2404 in the same direction, as seen best in FIGS. 17C-17D. The plug tip2456 may be tapered on at least two sides 2462, 2464 with respect to theplug body to facilitate insertion into a joint. The plug sides 2460,2462, 2464, 2466 may be smooth as seen in FIGS. 17A-17D; in otherembodiments one or more plug sides may include teeth, serrations, orother surface roughening. In other embodiments, the plug may have adifferently shaped cross-section. The plug does not preclude compressionof the bone segments by the bone engaging members 2402, 2404, at leastbecause the plug is oriented in a plane coplanar with, or parallel to,the plane of the bridge 2406 and bone engaging members 2402, 2404 of theclip 2400, as shown in FIG. 17C.

A means of insertion may maintain the clip 2400 in a first configurationthereby allowing a second configuration once an inserter is disassembledfrom the implant. The first configuration may be an elastically deformedstate, for example an insertion state. The second configuration may be afree state or an implanted state, as seen in FIG. 17A. The means ofinsertion may utilize features similar to connecting means 2414 and 2416in combination with other surfaces such as top surface 2408. Thiscombination of means of insertion may be used to maintain one or morefeatures or arms or projections in a particular configuration. Thiscombination of means of insertion may create a bending modality, such asa three point or four point bend, to maintain a specific clip deviceconfiguration or combination of configurations. A combination ofsurfaces and means of insertion, such as connecting means 2414, may beused on the entire clip or portions of a clip to create or maintain aparticular configuration of a clip. For example, a tab such as 2414 andtop surface, such as 2408 may be used to maintain one side of a clip orone leg of a clip in a particular configuration. When disassembled, thatleg may have a configuration that is different from or the same as theconfiguration of the rest of the clip.

Referring to FIGS. 17A-17B, the clip 2400 is shown in the free state, orrelaxed state, which is the shape of the clip 2400 when no externalforces are acting upon the clip 2400, other than gravity; the clip 2400experiences no elastic or plastic deflection or deformation. In the freestate, the bone engaging members 2402 and 2404 converge as they extendaway from the bridge 2406 so that the distal ends 2436, 2440 are closertogether than are the proximal ends 2434, 2438. An angle 2422 is formedbetween the converging bone engaging members 2402 and 2404 in the freestate. The angle 2422 opens toward the bridge 2406. The angle 2422 maybe referred to as a free state angle.

Referring to FIGS. 18A-18D, a drill guide 2500 may be employed toprepare pilot holes for implant 2400 in a joint 2 between a first bone 4and a second bone 6. The joint 2 may be an actual anatomical joint, anosteotomy, a fracture, or an interface between the first and secondbones 4, 6. Drill guide 2500 may include a handle portion 2502 and aguide portion 2504; some embodiments may exclude the handle portion2502. The guide portion 2504 includes a guide bar 2510 from which one ormore guide elements may depend. In the embodiment depicted, guideportion 2504 includes first and second single hole guide elements 2512,2514. Other embodiments of the drill guide 2500 can include any numberand arrangement of guide elements corresponding to a particular implantor clip, or set of implants; and in other embodiments the guide elementsmay not depend from the guide bar. Guide element 2512 surrounds andsupports a first lumen 2522 and guide element 2514 surrounds andsupports a second lumen 2524. All the guide elements may include pointedor tapered distal tips to facilitate engagement with bone or tissuesduring the drilling procedure.

In the embodiment depicted, the first and second lumens 2522, 2524 arecircular in a transverse cross section, and each is shaped to guide adrill for drilling a single bore. In the embodiment shown, the first andsecond lumens 2522, 2524 are co-planar. In other embodiments, one ormore of the lumens may be out of the plane of the others.

Referring to FIGS. 19A-19B, a drill bit 2550 may be used with the drillguide 2500 to prepare pilot holes for implant 2400. The drill bit 2550extends between a distal end 2552 and a proximal end 2554. The distalend 2552 includes a cutting portion 2556 with side and/or end cuttingflutes. The proximal end 2554 includes a torque coupling portion 2558for connection to a powered or manual torque source, such as an electricdrill or a T-handle. The drill bit 2550 is shown with an optionalintermediate portion 2560 with an outer diameter that is larger than theouter diameter of the cutting portion 2556 and smaller than the outerdiameter of the torque coupling portion 2558. The drill bit 2550 mayinclude one or more depth marks and/or depth stops and/or indicia. Forexample, a shoulder 2562 between the cutting portion 2556 and theintermediate portion 2560 may serve as a depth mark or depth stop.Another depth mark 2564 is shown in the intermediate portion 2560proximal to the shoulder 2562. The shoulder 2562 and/or depth mark 2564may align with, or may make contact with, a corresponding feature of thedrill guide 2500. For example, the depth mark 2564 may align with theproximal side of the guide bar 2510 to indicate that the drill bit 2550has been advanced to the proper depth.

Referring to FIGS. 20A-20B, a punch guide 2600 may include a punch guidebody 2602 and a handle 2604. The punch guide 2600 is illustrated inexploded views in FIGS. 20A-20B and operatively assembled in FIGS.26A-27B.

The punch guide body 2602 may be a generally rectangular shape with adistal side 2606, a proximal side 2608, a handle-facing side 2610, aleft side 2612, and a right side 2614. A lumen 2616 extends through thepunch guide body 2602 between the distal and proximal sides 2606, 2608.The lumen 2616 may have a transverse cross section that is elongated ina left-right direction as shown. The cross-sectional shape may berectangular, oval, snowman, or another shape. An oval shape is shown.The lumen 2616 may be centered in the left-right width of the punchguide body 2602. Bilateral pegs 2618, 2620 extend distally from thedistal side 2606 to the left and right of the lumen 2616. The pegs 2618,2620 may have distal tapered or pointed tips as shown in FIG. 20B. Aboss 2622 may extend obliquely outwardly and proximally from thehandle-facing side 2610. The boss 2622 may be centered in the left-rightwidth of the punch guide body 2602. An internally threaded hole 2624 mayextend into the boss 2622.

The handle 2604 may be a generally cylindrical shaft that extendsbetween a distal end 2626 and a proximal end 2628. The distal end 2626may include an externally threaded distal tip portion 2630 with threadsthat are complementary to the internal threads in the hole 2624 of thepunch guide body 2602. The proximal end 2628 may function as a handle.

The punch guide 2600 may be assembled by threading the distal tipportion 2630 into the internally threaded hole 2624. In use, the punchguide body 2602 and handle 2604 are fixed together.

Referring to FIGS. 21A-21B, a punch 2650 may be used with the punchguide 2600 to prepare a slot to receive the plug 2450 of the clip 2400.The punch 2650 extends between a distal end 2652 and a proximal end2654. The punch 2650 may include four portions or segments along itsdistal-proximal length. A first portion 2656 may extend proximally fromthe distal end 2652. The first portion 2656 may have an elongatedcross-sectional shape that is complementary to the cross-sectional shapeof the lumen 2616 of the punch guide 2600. The distal-most aspect of thefirst portion 2656 may be sharpened or pointed to penetrate bone. Twopoints 2658, 2660 are shown, with a distal sharp concave profile betweenthe points. A second portion 2662 may extend proximally from the firstportion 2656. The second portion 2662 may have the same cross-sectionalshape as the first portion, outwardly offset so that the second portionis wider and/or thicker than the first portion. A third portion 2664 mayextend proximally from the second portion 2662. The third portion 2664may have a cross sectional shape that is similar to, or different from,the cross-sectional shapes of the first and second portions 2656, 2662,and which may be outwardly offset so that the third portion is widerand/or thicker than the second portion. The third portion 2664 is shownwith a rectangular cross-sectional shape. A transverse hole 2666 mayextend through the thickness of the punch 2650 in the third portion2664. A fourth portion 2668 may extend proximally from the third portion2664. The fourth portion 2668 may have a circular cross-sectional shapethat is outwardly offset so that the fourth portion is wider and/orthicker than the third portion 2664. The third and fourth portions 2664,2668, together or separately, may function as a handle. The fourthportion 2668 may function as a strike platform to impact the punch 2650distally into bone or proximally out of bone.

In an alternate embodiment, the punch guide 2600 and punch 2650 may becombined together in a single instrument. In one example of thisembodiment, the punch guide body 2602, handle 2604, and punch 2650 maybe formed together as a unitary part. In this example, the featurecorresponding to the punch 2650 may be equivalent to the first portion2656 shown in FIGS. 21A, 21B, and 27B, which is the portion thatprotrudes distally from the punch guide body 2602 between the pegs 2618,2620.

Referring to FIGS. 22A-22F, an inserter 2700 may be used with any of theimplants or clips disclosed herein. The inserter 2700 may include a body2702, a ram 2704, a ram pin 2706, a knob 2708, a shaft 2710, and a knobpin 2712. The ram 2702 and the ram pin 2706 may be coupled together as aram sub-assembly 2714. The knob 2708, the shaft 2710, and the knob pin2712 may be coupled together as a shaft sub-assembly 2716.

The body 2702 extends between a distal end 2718 and a proximal end 2720.The body 2702 may be a generally plate-like part that is wider at thedistal end 2718 and narrower at the proximal end 2720. The distal-mostaspect of the body 2702 may include two jaws or hooks 2722, 2724 thatface each other across a shallow alcove 2726. The hooks 2722, 2724include proximal surfaces 2728, 2730, respectively. The hook 2722includes a front wall 2732 and the hook 2724 includes a back wall 2734.A notch 2736 extends proximally from a central portion of the alcove2726. A first slot 2738 extends through the body 2702 proximal to thenotch 2736 along a front-back direction. The slot 2738 is elongatedalong a proximal-distal direction. A second slot 2740 extends throughthe body 2702 proximal to the slot 2738 along the front-back direction.The slot 2740 is elongated along the proximal-distal direction. Thesecond slot 2740 is longer than the first slot 2738 in theproximal-distal direction and is wider than the first slot 2738 in theleft-right direction. A first central longitudinal hole 2742 extendsproximally into the body 2702 from the distal end 2718 to the slot 2740.The slot 2738 and the hole 2742 intersect at right angles. A secondcentral longitudinal hole 2744 extends distally into the body 2702 fromthe proximal end 2720 to the slot 2740. The hole 2744 may be internallythreaded. The body 2702 may be thickened in the vicinity of the hole2744 so as to adequately support the hole 2744 under expected loads.

The ram 2704 extends between a distal end 2750 and a proximal end 2752.The ram 2704 includes a distal head 2754, which may be generallyrectangular as shown. As seen best in FIGS. 22A and 22C, the distal-mostaspect of the head 2754 may be convex in a front or back view. A shaft2756 extends proximally from the head 2754. The shaft 2756 may have acircular cross section as shown. The outer diameter of the shaft 2756may be similar to the thickness of the head 2754 in a front-backdirection, and may be less than the width of the head in a left-rightdirection. A transverse hole 2758 extends through the shaft 2756 nearthe proximal end 2752.

The ram 2702 and the ram pin 2706 may be coupled together to form theram sub-assembly 2714 by inserting the ram pin through the hole 2758.

The knob 2708 may be a generally rectangular part which may be contouredto match the proximal end 2720 of the body 2702. A central longitudinalhole 2760 may extend through the knob in a proximal-distal direction. Atransverse hole 2762 may extend through the knob in a front-backdirection.

The shaft 2710 extends between a distal end 2770 and a proximal end2772. The shaft 2710 may include three portions or segments along itsdistal-proximal length. A first portion 2774 extends proximally from thedistal end 2770, has a circular cross section, and a smooth outersurface. A second portion 2778 extends proximally from the first portion2774 and has external threads 2780. The minor diameter of the externalthreads may be greater than the outer diameter of the first portion2774. A third portion 2782 extends proximally from the second portion2778 to the proximal end 2720, has a circular cross section, and asmooth outer surface. The outer diameter of the third portion 2782 maybe similar to the minor diameter of the external threads 2780. Atransverse hole 2784 extends through the third portion 2782 near theproximal end 2772.

The knob 2708, the shaft 2710, and the knob pin 2712 may be coupledtogether to form the shaft sub-assembly 2716 by inserting the thirdportion 2782 of the shaft 2710 into the hole 2760 of the knob 2708,aligning the transverse holes 2762, 2784, and inserting the knob pin2712 through the holes 2762, 2784.

The inserter 2700 may be assembled by inserting the shaft 2756 of theram 2704 into the hole 2742 of the body 2702, aligning the transversehole 2758 with the first slot 2738, and inserting the ram pin 2706through the slot 2738 and hole 2758; and by inserting the first portion2774 of the shaft 2710 into the hole 2744 of the body 2702 and advancingthe shaft distally relative to the body until the first portion entersthe hole 2742 and the external threads 2780 engage the internal threadsof the hole 2744. The head 2754 may be at least partially received inthe notch 2736. Referring to FIGS. 22C and 22D, the distal end 2770 ofthe shaft 2710 directly contacts the proximal end 2752 of the ram 2704,but the two parts are not otherwise mechanically connected.

When the inserter 2700 is operatively assembled, the ram 2704 is free totranslate proximal-distal relative to the body 2702 within theconstraint provided by the ram pin 2706 in the slot 2738, but the ram isprevented from rotating about its shaft 2756 relative to the body by theram pin in the slot. The shaft sub-assembly 2716 engages the body 2702via the external threads 2780 engaged with the internal threads of thehole 2744. Thus the shaft sub-assembly rotates and translatessimultaneously relative to the body. The shaft sub-assembly 2716 isremovable from the assembled body 2702, ram 2704, and ram pin 2706,which is advantageous at least for cleaning. Turning the knob 2708clockwise advances the shaft sub-assembly 2716 distally, which pushesthe ram sub-assembly 2714 distally. Turning the knob 2708counterclockwise moves the shaft sub-assembly proximally, which permitsthe ram sub-assembly to move proximally under an external force such asthe elastic force of a clip bridge or the force of gravity. However, thedistal end 2770 of the shaft 2710 is not mechanically coupled to theproximal end 2752 of the ram 2704 in a way that enables the shaftsub-assembly 2716 to pull the ram sub-assembly 2714 proximally.

The inserter 2700 may be coupled to any implant or clip disclosedherein. Clip 2400 will be used as an example. A method of coupling theinserter 2700 to the clip 2400 may include any or all of the followingsteps in any order: rotating the knob 2708 counterclockwise; rotatingthe shaft 2710 counterclockwise; rotating the shaft sub-assembly 2714clockwise; moving the ram 2704 proximally; moving the ram sub-assembly2714 proximally; positioning the upper surface 2408 of the bridge 2406of the clip 2400 against the distal-most aspect of the ram 2704;orienting the bridge 2406 relative to the body 2702 so that the frontwall 2732 is in front of the connecting means 2414 and the back wall2734 is in back of the connecting means 2416; orienting the bridge 2406relative to the body 2702 so that the longitudinal direction establishedby the bridge is oblique to the left-right direction between the hooks2722, 2724; rotating the body 2702 clockwise; sliding the hooks 2722,2724 under the connecting means 2414, 2416; rotating the knob 2708clockwise; rotating the shaft 2710 clockwise; rotating the shaftsub-assembly 2714 clockwise; moving the ram 2704 distally relative tothe body 2702; moving the ram sub-assembly 2714 distally relative to thebody 2702; and contacting the upper surface 2408 of the bridge 2406 ofthe clip 2400 with the distal-most aspect of the ram 2704.

The inserter 2700 may be disconnected from the implant 2400 at least byreversing the assembly steps.

When the implant 2400 and the inserter 2700 are operatively assembled,the inserter 2700 may be actuated to move the implant 2400 between thefree state and an elastically deformed state. Referring to FIG. 22C,clockwise rotation of the knob 2708, the shaft 2710, or the shaftsub-assembly 2716 causes the ram 2704 or the ram sub-assembly 2714 tomove distally relative to the body 2702 against the static resistance orsupport of the hooks 2722, 2724 or other static support feature(s). Thiscauses the bridge 2406 to elastically deform in three or four pointbending, which causes the bone engaging members 2402, 2404 to spreadapart. Counterclockwise rotation of the knob 2708, the shaft 2710, orthe shaft sub-assembly 2716 causes the ram 2704 or the ram sub-assembly2714 to move proximally relative to the body 2702, reducing the proximalforce of the hooks 2722, 2724 on the connecting means 2414, 2416. Thisallows the implant 2400 to relax toward the free state.

A surgical method for stabilizing first and second bone fragments mayinclude any or all of the following steps in any order: assembling thepunch guide 2600; assembling the inserter 2700; assembling the implant2400 and the inserter 2400; actuating the inserter 2400; moving the ram2704 or the ram sub-assembly 2714 distally relative to the body 2702;moving the implant 2400 from the free state to an elastically deformedstate; moving the bone engaging members 2402, 2404 from adistally-converging state to a parallel state; creating a first hole ina first bone fragment; creating a second hole in a second bone fragment;creating a third hole in the first and second bone fragments; insertingthe left bone engaging member 2402 in the first hole; inserting theright bone engaging member 2404 in the second hole; inserting the plug2450 in the third hole; seating the lower surface 2410 against a surfaceof the first or second bone fragment; releasing the inserter 2700;moving the ram 2704 or the ram sub-assembly 2714 proximally relative tothe body 2702; moving the implant 2400 from the elastically deformedstate toward the free state; moving the bone engaging members 2402, 2404from a parallel state toward a distally-converging state; anddisconnecting the inserter 2700 from the implant 2400.

Creating the first and second holes may include the steps of:positioning the guide element 2512 of the drill guide 2500 against thefirst bone fragment; positioning the guide element 2514 against thesecond bone fragment so that the guide elements 2512, 2514 are on eitherside of an interface between the first and second bone fragments;inserting the drill bit 2550 through the first lumen 2522 of the drillguide 2500; rotating the drill bit 2550 to form the first hole in thefirst bone fragment; inserting the drill bit 2550 through the secondlumen 2524; and rotating the drill bit 2550 to form the second hole inthe second bone fragment.

Creating the third hole in the first and second bone fragments mayinclude the steps of: inserting the peg 2618 of the punch guide 2600 inthe first hole; inserting the peg 2620 in the second hole; inserting thefirst portion 2656 of the punch 2650 in the lumen 2616 of the punchguide 2600; advancing the punch 2650 in the lumen 2616; impacting thepunch; and abutting the third portion 2664 of the punch 2650 against theproximal side 2608 of the punch guide body 2602.

FIG. 23 shows a joint 2 between a first bone 4 and a second bone 6.

FIG. 24 shows the steps of positioning the guide element 2512 of thedrill guide 2500 against the first bone fragment 4; positioning theguide element 2514 against the second bone fragment 6 so that the guideelements 2512, 2514 are on either side of an interface 2 between thefirst and second bone fragments 4, 6; and inserting the drill bit 2550through the first lumen 2522 of the drill guide 2500; rotating the drillbit 2550 to form the first hole in the first bone fragment 4.

FIG. 25 shows the joint 2 after creating first and second holes 2492,2494 in the first and second bone fragments 4, 6.

FIGS. 26A and 26B show the steps of inserting the peg 2618 of the punchguide 2600 in the first hole 2492; and inserting the peg 2620 in thesecond hole 2494.

FIGS. 27A and 27B show the steps of inserting the first portion 2656 ofthe punch 2650 in the lumen 2616 of the punch guide 2600; advancing thepunch 2650 in the lumen 2616; impacting the punch; and abutting thethird portion 2664 of the punch 2650 against the proximal side 2608 ofthe punch guide body 2602.

FIG. 28 shows the joint 2 after creating the third hole 2496 in thefirst and second bone fragments 4, 6.

FIG. 29 shows the steps of assembling the implant 2400 and the inserter2400; actuating the inserter 2400; moving the ram 2704 or the ramsub-assembly 2714 distally relative to the body 2702; moving the implant2400 from the free state to an elastically deformed state; moving thebone engaging members 2402, 2404 from a distally-converging state to aparallel state; inserting the left bone engaging member 2402 in thefirst hole 2492; and inserting the right bone engaging member 2404 inthe second hole 2494.

FIG. 30 shows the steps of inserting the plug 2450 in the third hole2496; and seating the lower surface 2410 against a surface of the firstor second bone fragment. FIG. 31 is an oblique detail view of the distalend of the inserter 2700 coupled to the implant 2400.

FIGS. 32 and 33 show the implant 2400 fully seated in the bone fragments4, 6.

Referring to FIG. 34, an implant and instrument system 3000 may includean implant 3100 and one or more instruments. The system 3000 is shownwith an implant or clip 3100, an inserter 3200, a drill guide assembly3300, a broach guide 3400, a punch 3500, a broach removal knob 3600, atamp 3700, a k-wire 3750, a reamer 3800, and a bone pin 3850.

Referring to FIGS. 35-42, the clip 3100 and inserter 3200 are shownoperatively assembled, with the clip 3100 in the free state, or relaxedstate.

The clip 3100 includes an integrated anti-torque plug 3150. Clip 3100and other clips disclosed herein may also be referred to as a fastener,staple, or implant. Anti-torque plug 3150 and other anti-torque featuresdisclosed herein may also be referred to as a tab, keel, post, orimplant. One or more clips 3100 may be implanted in a single procedure,for example to join two bone portions together. The clip 3100 may besimilar to the implant or clip 2400.

Referring to FIGS. 37 and 38, the clip 3100 includes bone engagingmembers 3102 and 3104 which may be integral to a clip bridge 3106, alsoreferred to as a clip body. The bone engaging members 3102 and 3104 maybe referred to as legs. In other embodiments within the scope of thedisclosure, a clip may include more than two bone engaging members; oralternatively may include openings for one or more independent fastenersin lieu of the bone engaging members. In other embodiments of thedisclosure, the implant 3100 may be more similar to a plate. The boneengaging member 3102 extends from a left end 3130 of the clip bridge3106 and the bone engaging member 3104 extends from an opposite rightend 3132 of the clip bridge 3106. Bone engaging member 3102 has aproximal end 3134 attached to the left end 3130 of the clip bridge 3106and an opposite distal end 3136 which is a free end. Bone engagingmember 3104 has a proximal end 3138 attached to the right end 3132 ofthe clip bridge 3106 and an opposite distal end 3140 which is a freeend. Clip bridge 3106 has at least one upper or proximal surface 3108and at least one lower or distal surface 3110. The lower surface 3110may be referred to as a bone facing surface. Bone engaging member 3102extends from the lower surface 3110 beside bone engaging member 3104.The bone engaging members 3102 and 3104 may have features 3112 that mayimprove bone purchase or improve pull out strength of the clip 3100 frombone or soft tissue. The features 3112 may be referred to as teeth orserrations. The features 3112 may be on facing sides of the boneengaging members 3102, 3104 or on any or all sides of the bone engagingmembers. The clip 3100 may have projections or other connecting means3114 and 3116 for connection with a means of insertion. The connectingmeans 3114, 3116 may be referred to as tabs, ears, protrusions, wings,retainers, or retaining members. The connecting means 3114 and 3116 areshown extending sideways outwardly from the left and right ends 3130,3132 of the bridge 3106, respectively, along a longitudinal directionestablished by the bridge. In other embodiments, the connecting meansmay project perpendicularly with respect to the bridge. The connectingmeans 3114 and 3116 may have lower or distal surfaces 3118 and 3120respectively that may releasably engage with a means of insertion thatmay allow an inserter or other means of insertion to be side loading,top loading or pivotably loaded. For example, an inserter for clip 3100may be side loading or pivotably loading. The lower surfaces 3118, 3120may be referred to as bone facing surfaces. Referring to FIG. 41, thelower surfaces 3118, 3120 are proximally spaced apart from, orproximally offset from, the lower surface 3110. The dashed extensionlines 3110′ and 3110″ in FIG. 41 show the level of the lower surface3110 versus the lower surfaces 3118, 3120.

An integrated anti-torque plug 3150 projects distally from the lowersurface 3110 of bridge 3106. In the embodiment depicted, a single plug3150 is centered between bone engaging members 3102, 3104; in otherembodiments the plug may be off-center relative to the members 3102,3104, and/or a plurality of plugs may be included. The plug may also beconnected to the implant 3100 in more than one location along the lowersurface 3110 of bridge 3106. Plug 3150 includes a neck portion 3152where the plug is joined to bridge 3106, a body 3154, and a tip 3156.Neck portion 3152 may be formed as a waist having a reduced width withrespect to the plug body 3154 as shown in FIG. 39; in other embodimentsthe neck portion 3152 may be wider than or equal in width with respectto the plug body 3154. Preferably, plug 3150 is connected to the clip3100 only via the bridge 3106, and not along the bone engaging members3102, 3104. Plug 3150 may be rectangular in cross-section and includesfour sides 3160, 3162, 3164, 3166. Plug 3150 may have another elongatedcross-sectional shape, such as oval, polygonal, elliptical, etc., Theplug thickness between sides 3160 and 3166 may be less than, the sameas, similar to, or greater than the thickness of the bridge 3106 and/orbone engaging members 3102, 3104 of the clip 3100 in the same direction(front-back). Preferably, the plug thickness between sides 3160 and 3166is less than the thickness of the bridge and bone engaging members 3102,3104 in the same direction, as seen best in FIG. 42. Preferably, thethickness of the bridge 3106 is greater than the thickness of the boneengaging members 3102, 3104, as seen best in FIG. 42; referring to FIG.38, the bridge 3106 may decrease in thickness toward the left and rightends 3130, 3132 and connecting means 3114, 3116. The major front-backdimension of the bridge 3106 may be 5 mm, the front-back dimension ofthe connecting means 3114, 3116 may be 2.7 mm, and the front-backdimension of the plug 3150 between sides 3160 and 3166 may be 1 mm. Theplug tip 3156 may be tapered on at least two sides 3162, 3164 withrespect to the plug body to facilitate insertion into a joint. The plugsides 3160, 3162, 3164, 3166 may be smooth as seen in FIGS. 37 and 38;in other embodiments one or more plug sides may include teeth,serrations, or other surface roughening. In other embodiments, the plugmay have a differently shaped cross-section. The plug does not precludecompression of the bone segments by the bone engaging members 3102,3104, at least because the elongated cross-section of the plug 3150 isoriented in a plane coplanar with, or parallel to, the plane of thebridge 3106 and bone engaging members 3102, 3104 of the clip 3100, asshown in FIGS. 41 and 42. In other words, the cross-section of the plug3150 is elongated along a direction parallel to, or colinear with, aline extending between the bone engaging members 3102, 3104.

A means of insertion may maintain the clip 3100 in a first configurationthereby allowing a second configuration once an inserter is disassembledfrom the implant. The first configuration may be an elastically deformedstate, for example an insertion state. The second configuration may be afree state or an implanted state, as seen in FIG. 39. The means ofinsertion may utilize features similar to connecting means 3114 and 3116in combination with other surfaces such as top surface 3108. Thiscombination of means of insertion may be used to maintain one or morefeatures or arms or projections in a particular configuration. Thiscombination of means of insertion may create a bending modality, such asa three point or four point bend, to maintain a specific clip deviceconfiguration or combination of configurations. A combination ofsurfaces and means of insertion, such as connecting means 3114, may beused on the entire clip or portions of a clip to create or maintain aparticular configuration of a clip. For example, a tab such as 3114 andtop surface, such as 3108 may be used to maintain one side of a clip orone leg of a clip in a particular configuration. When disassembled, thatleg may have a configuration that is different from or the same as theconfiguration of the rest of the clip.

Referring to FIG. 39, the clip 3100 is shown in the free state, orrelaxed state, which is the shape of the clip 3100 when no externalforces are acting upon the clip 3100, other than gravity; the clip 3100experiences no elastic or plastic deflection or deformation. In the freestate, the bone engaging members 3102 and 3104 converge as they extendaway from the bridge 3106 so that the distal ends 3136, 3140 are closertogether than are the proximal ends 3134, 3138. An angle 3122 is formedbetween the converging bone engaging members 3102 and 3104 in the freestate. The angle 3122 opens toward the bridge 3106. The angle 3122 maybe referred to as a free state angle.

The inserter 3200 may be used with any of the implants or clipsdisclosed herein. The inserter 3200 may include a body 3202, a ram orshaft 3204, a pin 3206, and a knob 3208. The inserter 3200 may besimilar to inserter 2700. The ram 3204 and the ram pin 3206 may becoupled together as a ram sub-assembly 3214.

The body 3202 extends between a distal end 3218 and a proximal end 3220.The body 3202 may be a generally plate-like part that is wider at thedistal and proximal ends 3218, 3220 and narrower in between. Thedistal-most aspect of the body 3202 may include two jaws or hooks 3222,3224 that face each other across a shallow alcove 3226. The hooks 3222,3224 include proximal surfaces 3228, 3230, respectively. The hooks 3222,3224 include front walls 3232, 3234, respectively. A first notch 3236extends proximally from a central portion of the alcove 3226. A secondnotch 3238 extends proximally from a central portion of the first notch3236. The second notch 3238 is narrower than the first notch 3236. Acentral longitudinal hole 3242 extends proximally through the body 3202between the distal and proximal ends 3218, 3220. The body 3203 may bethickened in the vicinity of the hole 3242 so as to adequately supportthe hole 3242 under expected loads. A third notch 3244 extends distallyinto a central portion of the proximal end 3220 and intersects atransverse slot 3246 that extends between the front and back sides ofthe body 3202.

The ram or shaft 3204 extends between a distal end 3250 and a proximalend 3252. The ram 3204 includes a distal head 3254, which may begenerally rectangular as shown. As seen best in FIGS. 39 and 41, thedistal-most aspect of the head 3254 may be convex in a front or backview. A shaft 3256 extends proximally from the head 3254. The shaft 3256may have a circular cross section as shown. The outer diameter of theshaft 3256 may be greater than the thickness of the head 3254 in afront-back direction, and may be less than the width of the head in aleft-right direction, as seen best in FIGS. 41 and 42. A transverse hole3258 extends through the shaft 3256 proximal to the head 3254. Theproximal end 3252 of the ram 3204 may include external threads 3259.

The ram 3204 and the ram pin 3206 may be coupled together to form theram sub-assembly 3214 by inserting the ram pin through the hole 3258.The ram pin 3206 may be fixed within the hole 3258 by a press fit,swaging operation, welding or brazing operation, or the like.

The knob 3208 may include a generally rectangular body 3262 which may becontoured to match the proximal end 3220 of the body 3202. A centrallongitudinal internally threaded hole 3260 may extend through the knob3208 along a proximal-distal direction. The knob 3208 may include afirst shaft portion 3264 extending distally from the body 3262concentric with the hole 3260. The outer diameter of the first shaftportion 3264 may be less than the outer dimensions of the body 3262 in afront, back, left, or right view. A second shaft portion 3266 may extenddistally from the first shaft portion 3264 concentric with the hole3260. The outer diameter of the second shaft portion 3266 may be greaterthan the outer diameter of the first shaft portion 3264.

The inserter 3200 may be assembled by coupling the knob 3208 to the body3202 so that the first shaft portion 3264 is in the third notch 3244 andthe second shaft portion 3266 is in the transverse slot 3246; insertingthe ram pin 3206 into the hole 3258 of the ram 3204 to form the ramsub-assembly 3214; inserting the proximal end 3252 of the ram into thedistal end of the hole 3242 of the body 3202; advancing the ramproximally until the proximal end 3252 reaches the knob 3208; andengaging the external and internal threads 3259, 3260 so that the head3254 is received in the first notch 3236 and the pin 3206 is received inthe second notch 3238.

When the inserter 3200 is assembled, the ram 3204, pin 3206, and knob3208 are captive to the body 3202. Clockwise and counterclockwiserotation of the knob 3208 causes the ram 3204 to translate along theproximal-distal direction. The pin 3206 in the second notch 3238prevents the ram 3204 from rotating and limits the proximal travel ofthe ram. However, there is no limit to the distal travel of the ram inthis embodiment, so that the inserter 3200 is readily disassembled forcleaning.

The clip 3100 and inserter 3200 may be operatively assembled by turningthe knob 3208 to move the ram 3204 proximally so that the distal aspectof the head 3254 is within the first notch 3236; sliding the hooks 3222,3224 over the connecting means 3114, 3116; and turning the knob 3208 tomove the ram 3204 distally so that the distal aspect of the head 3254contacts the bridge 3106. The connecting means 3114, 3116 may contactthe front walls 3232, 3234.

When the clip 3100 and inserter 3200 are operatively assembled,clockwise and counterclockwise rotation of the knob 3208 causes thebridge 3106 to move between an elastically deformed state and a relaxedstate, or free state. In the elastically deformed state, the distalaspect of the head 3254 presses against the proximal surface 3108 of thebridge 3106, flattening the bridge against the resistance of theconnecting means 3114, 3116 in the hooks 3222, 3224 and spreading apartthe free ends 3136, 3140 of the bone engaging members 3102, 3104. In therelaxed state, the distal aspect of the head 3254 may be spaced apartfrom the proximal surface 3108 of the bridge 3106, or may contact theproximal surface 3108 so lightly that the bridge remains undeformed.

Referring to FIGS. 43-45, the drill guide assembly 3300 may include ahandle 3302 and a guide 3304. The drill guide assembly 3300 may besimilar to the drill guide 2500. The drill guide assembly 3300 may beused to prepare holes in a first bone 4 and a second bone 6 on eitherside of a joint 2. The joint 2 may be an anatomical joint, an osteotomy,a fracture, or an interface between the first and second bones 4, 6.

The handle 3302 necks down to an externally threaded distal tip 3306,seen in FIG. 45.

The guide 3304 includes first and second guide elements 3312, 3314. Thefirst guide element 3312 surrounds and supports a first lumen 3322,while the second guide element 3314 surrounds and supports a secondlumen 3324. In the embodiment shown, the first and second lumens 3322,3324 are coplanar. In other embodiments, the lumens may not be coplanar.Each guide element 3312, 3314 includes a pointed or tapered distal tipto facilitate engagement with bone or tissues during use. The guideelements 3312, 3314 are carried by a generally Y- or V-shaped body 3310.A linear slot 3316 extends in a plane perpendicular to the plane of thefirst and second lumens 3322, 3324, and is located halfway between thefirst and second lumens. The slot 3316 may be replaced by a hole, alumen, a ring, or the like. An internally threaded hole 3326 extendsinto the body 3310 opposite the slot 3316.

The drill guide assembly 3300 may be assembled by threading the distaltip 3306 of the handle 3302 into the hole 3326 of the guide 3304. Whenthe drill guide assembly 3300 is assembled, the handle 3302 and guide3304 may be rigidly fixed together.

Referring to FIGS. 46-48, the punch 3500 and broach removal knob 3600are shown operatively assembled in FIGS. 46 and 47, and separated inFIG. 48.

The punch 3500 extends between a distal end 3502 and a proximal end3504. The punch 3500 may include four portions or segments along itsdistal-proximal length. A first portion 3506 may extend proximally fromthe distal end 3502. The first portion 3506 may have an elongatedcross-sectional shape. The distal-most aspect of the first portion 3506may be sharpened or pointed to penetrate bone. Two points 3508, 3510 areshown, with a distal sharp concave profile between the points. A secondportion 3512 may extend proximally from the first portion 3506. Thesecond portion 3512 may have the same cross-sectional shape as the firstportion, outwardly offset so that the second portion is wider and/orthicker than the first portion. A third portion 3514 may extendproximally from the second portion 3512. The third portion 3514 may haveexternal threads. A fourth portion 3518 may extend proximally from thethird portion 3514. The fourth portion 3518 may increase in diametertoward the proximal end 3504. The fourth portion 3518 may function as ahandle and a strike platform to impact the punch 3500 distally intobone. A transverse hole 3516 may extend through the thickness of thepunch 3500 in the fourth portion 3518.

The broach removal knob 3600 is a cylindrical part with a centrallongitudinal internally threaded hole 3602. The outer diameter of thebroach removal knob 3600 may include a grip feature, such as thecircular array of longitudinal grooves shown, knurling, flats, or thelike.

The punch 3500 and broach removal knob 3600 may be operatively assembledby threading the third portion 3514 of the punch 3500 into the hole 3602of the broach removal knob 3600.

Referring to FIGS. 49-50, the broach guide 3400 may be a generallyrectangular shape with a distal side 3406, a proximal side 3408, a leftside 3412, and a right side 3414. The broach guide 3400 may be similarto the punch guide 2600, and may be referred to as a punch guide itself.A lumen 3416 extends through the broach guide 3400 between the distaland proximal sides 3406, 3408. The lumen 3416 may have a transversecross section that is elongated in a left-right direction as shown. Thecross-sectional shape may be rectangular, oval, snowman, or anothershape. An oval shape is shown. The lumen 3416 may be sized and shaped toreceive the first and second portions 3506, 3512 of the punch 3500. Thelumen 3416 may be centered in the left-right width of the broach guide3400. Bilateral pegs 3418, 3420 extend distally from the distal side3406 to the left and right of the lumen 3416. The pegs 3418, 3420 mayhave distal tapered or pointed tips as shown in FIG. 49. The pegs may beseparate parts or integrally formed with the broach guide 3400. The pegs3418, 3420 fit into the holes in the first and second bones 4, 6 madeusing the drill guide assembly 3300. A transverse hole 3422 may extendthrough the broach guide 3400 along a front-back direction, and may becentered in the left-right width of the broach guide 3400 near theproximal end 3408. The hole 3422 may intersect the lumen 3416.

The punch 3500, with attached broach removal knob 3600, and broach guide3400 may be operatively assembled by inserting the first portion 3506 ofthe punch 3500 into the lumen 3416 at the proximal side 3408 of thebroach guide 3400 and advancing the punch 3500 distally until the distalend of the third portion 3514 contacts the proximal side 3408 of thebroach guide 3400 and at least a distal portion of the first portion3506 protrudes from the distal end of the lumen 3416. Preferably, thebroach removal knob 3600 is assembled to the punch 3500 in contact withthe distal end of the fourth portion 3518.

When the punch 3500, broach removal knob 3600, and broach guide 3400 areoperatively assembled, the punch 3500 may be advanced distally throughthe broach guide 3400 to prepare a slot across the joint 2 between thefirst and second bones 4, 6. The broach removal knob 3600 may be rotatedrelative to the punch 3500 to move the broach removal knob distally topush against the broach guide 3400 to push the punch 3500 proximally outof the bones 4, 6 and the broach guide.

Referring to FIG. 34, the tamp 3700 may be an elongated generallyrectangular solid part with a hole 3702 through each end. The tamp 3700may be employed to push the implant 3100 farther into the first andsecond bones 4, 6 after the inserter 3200 has been disconnected from theimplant 3100.

The k-wire 3750 is sized to be received in the slot 3316 of the drillguide assembly 3300. The k-wire 3750 may be replaced by a bone pin,drill bit, reamer, peg, rod, shaft, dowel, and the like. The k-wire 3750may be replaced by a part having a non-circular transverse crosssection, such as an oval or rectangular cross section, similar to thetamp 3700. This may be advantageous when the part is inserted into thejoint 2, as such a part will tend to orient itself with the majorcross-sectional dimension oriented along the joint 2. When the part isreceived in a complementary slot 3316, the drill guide assembly 3300will be oriented more precisely perpendicular to the joint 2, andsubsequently the broach guide 3400, punch 3500, and implant 3100 will beoriented more precisely perpendicular to the joint 2.

The reamer 3800 and the bone pin 3850 are sized to be received in eitherlumen 3322, 3324 of the drill guide assembly 3300.

A surgical method for using the system 3000 to stabilize first andsecond bone fragments may include any or all of the following steps inany order:

Inserting the k-wire 3750 into a desired location for implant 3100placement relative to the joint 2 and the first and second bones 4, 6.The k-wire 3750 indicates where the midpoint of the plug 3150 will belocated when the implant 3100 is inserted. The k-wire 3750 may beinserted in the joint 2 between first and second bones 4, 6 so that theplug 3150 will be centered across the joint 2.

Positioning the drill guide assembly 3300 relative to the joint 2, thefirst and second bones 4, 6, and the k-wire 3750 so that the distal tipof the first guide element 3312 is against the first bone 4, the distaltip of the second guide element 3314 is against the second bone 6, andthe slot 3316 receives the k-wire 3750.

Actuating the reamer 3800 through the first lumen 3322 to make a hole inthe first bone 4, removing the reamer, and optionally inserting the bonepin 3850 into the prepared hole in the first bone 4.

Actuating the reamer 3800 through the second lumen 3324 to make a holein the second bone 6, and removing the reamer, drill guide assembly3300, and k-wire 3750.

Inserting the pegs 3418, 3420 of the broach guide 3400 into the holes inthe first and second bones 4, 6 and advancing the broach guide 3400against the first and second bones 4, 6.

Threading the broach removal knob 3600 onto the third portion 3514 ofthe punch 3500 and into contact with the distal end of the fourthportion 3518.

Inserting the first portion 3506 of the punch 3500 into the proximal endof the lumen 3416 of the broach guide 3400 and advancing the punch 3500distally until the distal end of the third portion 3514 contacts theproximal side 3408 of the broach guide 3400. The punch 3500 may beadvanced by impacting the proximal end of the fourth portion 3518 with amallet. The punch 3500, broach guide 3400, and plug 3150 may bedimensioned relative to each other so that when the distal end of thethird portion 3514 contacts the proximal side 3408, the first portion3506 protrudes from the distal end of the lumen 3416 a distance thatcorresponds to the location of the tip 3156 of the plug 3150 when theimplant 3100 is inserted. Thus, the punch 3500 forms a slot in the firstand second bones 4, 6 across the joint 2 (or across the desired locationas established by the k-wire 3750).

Removing the punch 3500, broach removal knob 3600, and broach guide 3400from the first and second bones 4, 6. The broach removal knob 3600 maybe rotated relative to the punch 3500 to move the broach removal knobdistally to push against the broach guide 3400 to push the punch 3500proximally out of the bones 4, 6 and the broach guide, if needed. Thebone pin 3850 may be inserted into the hole 3516 of the punch 3500 orthe hole 3422 of the broach guide 3400 to aid in removal, if needed.

Coupling the implant 3100 to the inserter 3200. This step may includeturning the knob 3208 to move the ram 3204 proximally so that the distalaspect of the head 3254 is within the first notch 3236; sliding thehooks 3222, 3224 over the connecting means 3114, 3116; and turning theknob 3208 to move the ram 3204 distally so that the distal aspect of thehead 3254 contacts the bridge 3106. The connecting means 3114, 3116 maycontact the front walls 3232, 3234.

Moving the implant 3100 to the elastically deformed state. This step mayinclude turning the knob 3208 to move the ram 3204 distally to pressagainst the proximal surface 3108 of the bridge 3106 to flatten thebridge against the resistance of the connecting means 3114, 3116 in thehooks 3222, 3224, thereby spreading apart the free ends 3136, 3140 ofthe bone engaging members 3102, 3104. Preferably, the bone engagingmembers 3102, 3104 are substantially parallel in the elasticallydeformed state, in other words parallel in the view of the user.

Inserting the bone engaging members 3102, 3104 into the holes in thefirst and second bones 4, 6, inserting the plug 3150 into the slot inthe first and second bones 4, 6, and advancing the implant 3100 into thefirst and second bones 4, 6 until the distal surface 3110 of the bridge3106 is flush against the first and second bones 4, 6.

Allowing the implant 3100 to move toward the relaxed state, or freestate. This step may include turning the knob 3208 to move the ram 3204proximally away from the bridge 3106.

Disconnecting the inserter 3200 from the implant 3100. This step mayinclude sliding the inserter 3200 along a front-back direction off ofthe connecting means 3114, 3116.

Optionally advancing the implant 3100 farther into the first and secondbones 4, 6 after the inserter 3200 has been disconnected from theimplant 3100. This step may include placing one end of the tamp 3700against the bridge 3106 and impacting the opposite end of the tamp witha mallet.

Referring to FIGS. 51-55, another embodiment of an implant with anassociated keel is shown. Implant 4000 includes a plate 4002 and theclip 200 (FIGS. 2A and 2B). The implant 4000 may also include one ormore fasteners, such as the two bone screws 2280 shown. The implant 4000may be similar to implant 2200 or assembly 100 disclosed in U.S. patentapplication Ser. No. 15/209,623, which is incorporated herein byreference in its entirety.

The plate 4002 has an obverse side 4012 and a reverse side 4014. Whenthe plate 4002 is implanted, the obverse side 4012 faces away from thefirst and second bones 4, 6 and the reverse side 4014 faces toward thefirst and second bones. The plate 4002 includes several holes 4016 whichextend through the plate 4002 between the obverse and reverse sides4012, 4014. Three holes 4016 are illustrated, although any number ofholes may be present. Each hole 4016 may include an internally threadedportion 4018 and/or a non-threaded portion 4020 so that each hole 4016may accept a locking screw or a non-locking screw. The internallythreaded portion 4018 may be adjacent to the reverse side 4014. Thenon-threaded portion 4020 may be adjacent to the obverse side 4012. Thenon-threaded portion 4020 may be concave and/or elongated. One end ofthe plate 4002 is shown with an optional hole 4021 with a concaveelongated non-threaded portion 4020 and no internally threaded portion.An optional groove 4022 in the obverse side 4012 extends between two ofthe holes 4016, and slightly beyond each of the holes. Each of these twoholes 4016 is also elongated toward the other hole 4016, leaving a web4024 extending between the two holes 4016. The web 4024 may be adjacentto the reverse side 4014. The web 4024 separates the two holes 4016, andmay be present even if the holes 4016 are not elongated towards eachother. The optional groove 4022 if present, the two holes 4016(elongated or not), and the web 4024 are referred to collectively as areceiver 4026, and the involved holes 4016 are referred to as receiverholes 4028. A receiver 4026 may be included between any two holesthrough a plate. Multiple receivers may be included on a single plate.For example, the plate 4002 may be modified to include a second receiverbetween the left two holes 4016 and/or a third receiver between theright two holes 4016. Two receivers 4026 may share a common receiverhole 4028. The plate 4002 may be much more stiff than the dynamicelement, which in this example is the clip or staple 200. The plate 4002may be rigid or static. Alternatively, the plate 4002 may be malleableor elastic. The plate 4002 may include rigid and malleable regions.

The plate 4002 includes an integral anti-torque plug 4050 which extendsfrom the reverse side 4014 of the web 4024. The plug 4050 may also bereferred to as a tab, keel, post, or the like. The plug 4050 is depictedas being centered on the web 4024 between the two receiver holes 4028;in other embodiments the plug may be off-center relative to the receiverholes 4028 and/or web 4024 and/or a plurality of plugs may be included.The plug may also be connected to the plate 4002 in more than onelocation along the reverse side 4014. Plug 4050 includes a neck portion4052 where the plug is joined to the web 4024, a body 4054, and a tip4056. Neck portion 4052 may be formed as a waist having a reduced widthwith respect to the web 4024 or the plate 4002, as shown in FIG. 54; inother embodiments the neck portion 4052 may be wider than or equal inwidth with respect to the web 4024 or the plate 4002. Preferably, plug4050 is connected to the plate 4002 only via the web 4024, and not alongthe remainder of the reverse side 4014. Plug 4050 may be rectangular incross-section and includes four sides 4060, 4062, 4064, 4066. The plugthickness between sides 4060 and 4066 may be less than, the same as,similar to, or greater than the thickness of the bridge 206 and/or boneengaging members 202, 204 of the clip 200 in the same direction(front-back). Preferably, the plug thickness between sides 4060 and 4066is less than the thickness of the bridge 206 and bone engaging members202, 204 of the clip 200 or the screws 2280 in the same direction, asseen best in FIGS. 51 and 52. The plug tip 4056 may be tapered on atleast two sides 4062, 4064 with respect to the plug body 4054 tofacilitate insertion into a joint 2. The plug sides 4060, 4062, 4064,4066 may be smooth as seen in FIGS. 51 and 52; in other embodiments oneor more plug sides may include teeth, serrations, or other surfaceroughening. In other embodiments, the plug may have a differently shapedcross-section. The plug does not preclude compression of the bonesegments by the bone engaging members 202, 204 of the clip 200 or thescrews 2280 at least because the plug is oriented in a plane coplanarwith, or parallel to, the plane of the bridge 206 and bone engagingmembers 202, 204 of the clip 200 and the screws 2280, as shown in FIGS.51 and 52. Advantageously, the plug 4050 sustains most of the torsionacross the joint 2, which relieves stress from the extracortical mainbody of the plate 4002. This means that the body of the plate 4002 maybe made thinner than a plate lacking the plug 4050.

The implant 4000 may be operatively assembled by inserting the distalends 236, 240 of the bone engaging members 202, 204 of the clip 200through the receiver holes 4028 of the plate 4002. The clip 200 may beadvanced until the lower surface 210 of the bridge 206 contacts theupper surface of the web 4024, so that the bridge 206 is at leastpartially within the groove 4022, if present. The bone engaging members202, 204 protrude through the reverse side 4014 of the plate 4002. Theclip 200 may be in the free state or an elastically deformed state. Theclip 200 may be coupled to any of the inserters 2700, 3200 disclosedherein, or in the documents incorporated by reference in thisapplication. The bilateral extensions of groove 4022 beyond the receiverholes 4028 may provide clearance for inserter jaws to engage anddisengage the connecting means 214, 216 of the clip 200 when the clip isfully advanced into the receiver 4026. The illustrated groove extensionsmay be particularly useful for inserters with jaws that engage theconnecting means 214, 216 along the longitudinal direction of the bridge206.

A surgical method for stabilizing the joint 2 between the first andsecond bones 4, 6 with the implant 4000 may include any or all of thefollowing steps in any order:

Preparing a bone slot for the plug 4050 across the joint 2 between thefirst and second bones 4, 6. This step may involve inserting a k-wire inthe joint 2, as described above for k-wire 3750, and referencing thek-wire with an instrument to center the bone slot over the joint 2.

Placing the plate 4002 against the first and second bones 4, 6 with theplug 4050 in the bone slot.

Preparing holes for the screws 2280 in the first and second bones 4, 6.This step may involve engaging guide elements of a drill guide with theintended screw holes, for example the left-most hole 4016 and the hole4021, and actuating a drill through each guide element to create onehole in the first bone 4 and a second hole in the second bone 6. Thisstep may optionally involve compressing the first and second bones 4, 6together before drilling the holes.

Inserting screws 2280 through the plate 4002 and into the bone holes forthe screws.

Preparing holes for the bone engaging members 202, 204 of the clip 200in the first and second bones 4, 6. This step may involve engaging guideelements of another drill guide with the receiver 4026, for example thereceiver holes 4028, and actuating a drill through each guide elementand the corresponding receiver hole 4028 to create one hole in the firstbone 4, and a second hole in the second bone 6. This step may optionallyinvolve compressing the first and second bones 4, 6 together beforedrilling the holes.

Inserting the bone engaging members 202, 204 of the clip 200 through thereceiver holes 4028 and into the bone holes for the bone engagingmembers. This step may involve coupling the clip 200 to an inserterand/or moving the clip into an elastically deformed state beforeinserting the bone engaging members through the receiver holes and intothe bone holes. This step may also involve allowing the clip 200 to movetoward the relaxed or free state by actuating the inserter and/ordisconnecting the inserter from the clip 200. These details arediscussed above.

The implants or clips disclosed herein may be made from nitinol,titanium, stainless steel, polymers including PEEK, or any materialproviding the elastic properties to allow the clip to providecompression across the joint. The plugs disclosed herein may be madefrom PEEK, titanium, stainless steel, allograft, UHMWPE or any otherbiocompatible material suitable to resist joint forces for a time.Additionally, any of these materials could be coated withosteoconductive coatings/surface treatments such as hydroxyapatite,trabecular metal, porous beads, and/or nanotubes, among others. It isappreciated that the use of the implants disclosed herein is not limitedto bone; any of the implants, clips, or plugs described herein may beimplanted into other tissues or materials.

The terms “upper” and “lower”, and “top” and “bottom”, “front”, “side”,and “rear” are used as relative terms herein for ease of description andunderstanding. It is understood that in embodiments of the disclosure,upper and lower entities may be reversed, as may top and bottom, frontand rear.

Any methods disclosed herein includes one or more steps or actions forperforming the described method. The method steps and/or actions may beinterchanged with one another. In other words, unless a specific orderof steps or actions is required for proper operation of the embodiment,the order and/or use of specific steps and/or actions may be modified.

Reference throughout this specification to “an embodiment” or “theembodiment” means that a particular feature, structure or characteristicdescribed in connection with that embodiment is included in at least oneembodiment. Thus, the quoted phrases, or variations thereof, as recitedthroughout this specification are not necessarily all referring to thesame embodiment.

Similarly, it should be appreciated that in the above description ofembodiments, various features are sometimes grouped together in a singleembodiment, figure, or description thereof for the purpose ofstreamlining the disclosure. This method of disclosure, however, is notto be interpreted as reflecting an intention that any claim require morefeatures than those expressly recited in that claim. Rather, as thefollowing claims reflect, inventive aspects lie in a combination offewer than all features of any single foregoing disclosed embodiment.Thus, the claims following this Detailed Description are herebyexpressly incorporated into this Detailed Description, with each claimstanding on its own as a separate embodiment. This disclosure includesall permutations of the independent claims with their dependent claims.

Recitation in the claims of the term “first” with respect to a featureor element does not necessarily imply the existence of a second oradditional such feature or element. Elements recited inmeans-plus-function format are intended to be construed in accordancewith 35 U.S.C. § 112 Para. 6. It will be apparent to those having skillin the art that changes may be made to the details of theabove-described embodiments without departing from the underlyingprinciples of the technology.

While specific embodiments and applications of the present technologyhave been illustrated and described, it is to be understood that thetechnology is not limited to the precise configuration and componentsdisclosed herein. Various modifications, changes, and variations whichwill be apparent to those skilled in the art may be made in thearrangement, operation, and details of the methods and systems of thepresent technology disclosed herein without departing from the spiritand scope of the technology.

The invention claimed is:
 1. A system for stabilizing a first bonerelative to a second bone, wherein a joint separates the first andsecond bones, the system comprising: a dynamic implant having first andsecond legs connected by a bridge, and having a plug extending from abone-facing side of the bridge, wherein the plug has a cross-sectionthat is elongated along a direction parallel to the bridge, wherein theimplant has a free state in which the legs converge as they extend awayfrom the bridge, and an elastically deformed state in which the legs aresubstantially parallel; a drill guide having first and second lumenscorresponding to the first and second legs of the implant; a punch guidehaving first and second pegs extending outwardly from a body, the firstand second pegs corresponding to the first and second legs of theimplant, and having a lumen extending through the body, the lumencorresponding to the cross-section of the plug; and a punch having acutting portion that has a cross-section that corresponds to thecross-section of the plug.
 2. The system of claim 1, wherein the firstand second legs of the implant extend from the bone-facing side of thebridge, wherein the plug is between the first and second legs.
 3. Thesystem of claim 1, wherein the plug is integral to the bridge.
 4. Thesystem of claim 3, wherein the plug comprises a neck portion that joinsto the bridge, wherein the neck portion has a reduced width relative toa remainder of the plug.
 5. The system of claim 1, wherein the plug is aseparate part that connects to the bridge.
 6. The system of claim 1,wherein when the cutting portion of the punch is inserted through thelumen of the punch guide, a distal end of the cutting portion of thepunch protrudes from the lumen of the punch guide between the first andsecond pegs.
 7. The system of claim 6, wherein the punch comprises ahandle extending from the cutting portion, wherein the handle has across-section that is wider or thicker than the cross-section of thecutting portion, wherein when the cutting portion of the punch isinserted through the lumen of the punch guide, the handle of the punchabuts the body of the punch guide and protrudes away from the punchguide opposite the protruding distal end of the cutting portion of thepunch.
 8. The system of claim 1, comprising: an inserter removablyconnectable to the implant, wherein actuation of the inserter moves theimplant between the free state and the elastically deformed state. 9.The system of claim 1, wherein the first and second pegs are integrallyformed with the body of the punch guide.
 10. The system of claim 1,wherein the first and second pegs are separate from the body of thepunch guide.
 11. A system for stabilizing a first bone relative to asecond bone, wherein a joint separates the first and second bones, thesystem comprising: a dynamic implant having first and second legsconnected by a bridge, and having a plug extending from a bone-facingside of the bridge, wherein the plug has a cross-section that iselongated along a direction parallel to the bridge, the plug is integralto the bridge, the plug comprises a neck portion that loins to thebridge, and the neck portion has a reduced width relative to a remainderof the plug, and wherein the implant has a free state in which the legsconverge as they extend away from the bridge, and an elasticallydeformed state in which the legs are substantially parallel; and a drillguide having first and second lumens corresponding to the first andsecond legs of the implant, and a third lumen corresponding to thecross-section of the plug.
 12. The system of claim 11, furthercomprising: a punch guide having first and second pegs extendingoutwardly from a body, the first and second pegs corresponding to thefirst and second legs of the implant, and having a lumen extendingthrough the body, the lumen corresponding to the cross-section of theplug; and a punch having a cutting portion that has a cross-section thatcorresponds to the cross-section of the plug.
 13. The system of claim12, wherein when the cutting portion of the punch is inserted throughthe lumen of the punch guide, a distal end of the cutting portion of thepunch protrudes from the lumen of the punch guide between the first andsecond pegs.
 14. The system of claim 13, wherein the punch comprises ahandle extending from the cutting portion, wherein the handle has across-section that is wider or thicker than the cross-section of thecutting portion, wherein when the cutting portion of the punch isinserted through the lumen of the punch guide, the handle of the punchabuts the body of the punch guide and protrudes away from the punchguide opposite the protruding distal end of the cutting portion of thepunch.
 15. The system of claim 11, wherein the first and second legs ofthe implant extend from the bone-facing side of the bridge, wherein theplug is between the first and second legs.
 16. The system of claim 11,wherein the plug is a separate part that connects to the bridge.
 17. Thesystem of claim 11, wherein the drill guide comprises a k-wire receivingfeature corresponding to a center of the plug, wherein the k-wirereceiving feature extends parallel to and between the first and secondlumens.
 18. The system of claim 11, comprising: an inserter removablyconnectable to the implant, wherein actuation of the inserter moves theimplant between the free state and the elastically deformed state. 19.The system of claim 12, wherein the first and second pegs are integrallyformed with the body of the punch guide.
 20. The system of claim 12,wherein the first and second pegs are separate from the body of thepunch guide.
 21. A system for stabilizing a first bone relative to asecond bone, wherein a joint separates the first and second bones, thesystem comprising: a dynamic implant having first and second legsconnected by a bridge, and having a plug extending from a bone-facingside of the bridge, wherein the plug has a cross-section that iselongated along a direction parallel to the bridge, wherein the implanthas a free state in which the legs converge as they extend away from thebridge, and an elastically deformed state in which the legs aresubstantially parallel; and a drill guide having first and second lumenscorresponding to the first and second legs of the implant, and a linearslot corresponding to a center of the plug, wherein the linear slotforms an elongate opening in a side of the drill guide that extendsparallel to and between the first and second lumens.
 22. The system ofclaim 21, further comprising: a punch guide having first and second pegsextending outwardly from a body, the first and second pegs correspondingto the first and second legs of the implant, and having a lumenextending through the body, the lumen corresponding to the cross-sectionof the plug; and a punch having a cutting portion that has across-section that corresponds to the cross-section of the plug.
 23. Thesystem of claim 22, wherein when the cutting portion of the punch isinserted through the lumen of the punch guide, a distal end of thecutting portion of the punch protrudes from the lumen of the punch guidebetween the first and second pegs.
 24. The system of claim 23, whereinthe punch comprises a handle extending from the cutting portion, whereinthe handle has a cross-section that is wider or thicker than thecross-section of the cutting portion, wherein when the cutting portionof the punch is inserted through the lumen of the punch guide, thehandle of the punch abuts the body of the punch guide and protrudes awayfrom the punch guide opposite the protruding distal end of the cuttingportion of the punch.
 25. The system of claim 21, wherein the first andsecond legs of the implant extend from the bone-facing side of thebridge, wherein the plug is between the first and second legs.
 26. Thesystem of claim 21, wherein the plug is integral to the bridge.
 27. Thesystem of claim 26, wherein the plug comprises a neck portion that joinsto the bridge, wherein the neck portion has a reduced width relative toa remainder of the plug.
 28. The system of claim 21, wherein the plug isa separate part that connects to the bridge.
 29. The system of claim 21,comprising: an inserter removably connectable to the implant, whereinactuation of the inserter moves the implant between the free state andthe elastically deformed state.
 30. The system of claim 22, wherein thefirst and second pegs are integrally formed with the body of the punchguide.
 31. The system of claim 22, wherein the first and second pegs areseparate from the body of the punch guide.
 32. The system of claim 21,wherein the linear slot is configured to receive a k-wire through theelongate opening.